FDA Scolds Medtronic Over Insulin Pump Violations

The Food and Drug Administration has warned medical device manufacturer Medtronic Inc. to take "prompt action" to correct production violations at a Puerto Rico facility where the company makes insulin pumps.

In the letter the agency told Medtronic that it considers Synchromed II pumps "adulterated" under federal law because of procedural violations uncovered at the manufacturing plant during an inspection last year.

According to the letter, FDA inspectors determined that Medtronic's "methods, facilities or controls" used in making the device do not meet the agency's "current good manufacturing practice" requirements.

Records kept at the company's factory in Juncos, Puerto Rico, falsely showed that operational tests were conducted on certain Synchromed II pumps released to the public, when the tests actually were not performed, the agency said.

In the letter the FDA told Medtronic it is "concerned with your failure to initiate a recall in a timely manner" for Synchromed II pumps that lack the proper amount of a crucial propellant.

Although the company announced a recall related to the propellant shortfall in May 2008, it knew of the problem two years earlier, according to the agency.

Further, the letter said, while factory records showed that the pumps were sterilized in accordance with FDA-approved standards, Medtronic has since acknowledged that the full sterilization process may not have been followed.

Agency inspectors also determined that the MiniMed Paradigm pumps are "misbranded" because Medtronic failed or refused to provide information on how quickly it forwards malfunction reports received from the field to the FDA, according to the letter.

Finally, the agency said, inspectors discovered that decisions on whether to notify the FDA about problematic MiniMed pumps were sometimes made by an employee who holds only a high school diploma and "some additional in-house training."

The FDA urged Medtronic to promptly address the violations. Failure to do so may result in "regulatory action being initiated without further notice," the agency said.

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