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The FDA has issued a warning letter to Medtronic Inc. about their Synchromed drug pump and MiniMed insulin pump, saying the company needs to fix deficiencies in quality control and reporting at a Puerto Rico plant that manufactures the medical devices.
The Medtronic warning letter lists a number of problems, including violations of federal regulations and good manufacturing practices at the facility, which were initially discovered during an inspection in late 2008.
The violations included failing to maintain process control procedures to make sure products conformed to their specifications, failing to ensure accurate records for each batch, lot or unit manufactured, failing to evaluate and investigate consumer complaints involving problems with the devices and failing to report problems where malfunctions could have resulted in serious injury or death.
The FDA notes in the letter that the individual problems it has found may be “symptomatic of serious problems in” Medtronic’s manufacturing and quality assurance procedures.
The letter criticizes the company for taking two years to recall the Synchromed II Pumps after the company discovered some models were missing a key propellant. The FDA letter states that Medtronic initially identified the problems with the pump in May 2006, but did not issue a recall or inform the FDA of the problem until May 2008. About 13,000 units were affected.
The FDA also noted several failures in Medtronic procedures that allowed the pumps with the missing propellant to go out, including the fact that a weight test indicating something was missing from the pumps was apparently ignored or overlooked. A lack of adequate device history records also allowed problems to slip through, the letter states.
Many of the problems also deal with failures in the facility’s reporting procedures and investigating complaints from consumers. The FDA alleges that Medtronic did not submit a consumer complaint regarding the MiniMed Paradigm Insulin Pump because the company determined that the malfunction being reported was unlikely to result in injury or death if it were to reoccur. However, the company had already reported several complaints on the exact same malfunction, having determined that those malfunctions could be life-threatening.
“The information in the complaint indicated that the user contacted your firm because the user had a blood glucose level of 456, and that the user’s MiniMed Paradigm Insulin Pump had failed to alarm when it stopped delivering insulin,” the warning letter states. “The user was subsequently hospitalized and diagnosed with diabetic ketoacidosis.”
The agency also criticized Medtronic for not having someone with the proper qualifications and training to make a medical judgment regarding the danger of device malfunctions. According to the FDA letter, Medtronic was employing a product reporting specialist for the insulin pump who only had a high school diploma and some “additional in-house training.”
Medtronic officials have stated that most of the problems at the Puerto Rico facility have been corrected since the FDA inspections, but the FDA has yet to determine if those corrections have been adequate.