BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1944436 · Received December 28, 2010

    Report

    Report Number
    3004464228-2010-01450
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    July 23, 2009
    Report Date
    November 18, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED PDM FOUND A SIGNIFICANT AMOUNT OF DEBRIS WITHIN THE BG METER PORT. THE PRESENCE OF DEBRIS CAN CAUSE AN INTERFERENCE WITH THE CONTACT SURFACES OF A TEST STRIP AND THE SENSORS, WHICH CAN DIRECTLY RESULT IN THE METER NOT RECOGNIZING A STRIP WHEN INSERTED. DEBRIS IN THE BG METER PORT IS ALSO KNOWN TO AFFECT BG READINGS, RESULTING IN ERRONEOUS OR "INCONSISTENT" READINGS (AS REPORTED). THE PRESENCE OF DEBRIS IN THE BG METER PORT IS THE RESULT OF USER NEGLIGENCE IN PROPERLY CARING FOR THE PDM AND IS IN NO WAY REFLECTIVE OF ANY MANUFACTURING OR PRODUCT RELATED ISSUE. THE PDM EVALUATION CONTINUED AFTER THE BG METER PORT WAS CLEANED AND THE DEBRIS WAS REMOVED FROM THE SURFACES OF THE SENSORS: THE RESULTS OF ALL BG READING TESTS WERE FOUND TO BE WITHIN SPECIFIED TOLERANCE LIMITS. THE BG METER FUNCTIONED AS INTENDED AFTER THE DEBRIS WAS REMOVED. THEREFORE, THE REPORTED "INCONSISTENT BG READINGS" ARE CONSIDERED TO HAVE BEEN CAUSED BY THE PRESENCE OF DEBRIS IN THE METER AND NOT BY ANY MANUFACTURING OR PRODUCT RELATED ISSUE. NOTE: THE MANUFACTURER HAD ORIGINALLY RECEIVED THIS COMPLAINT ON (B)(6) 2009. AT THAT TIME, A REGULATORY REPORTING ASSESSMENT HAD BEEN PERFORMED AND, BASED SOLELY ON THE INFORMATION PROVIDED IN THE CUSTOMER COMPLAINT, IT WAS DETERMINED THAT NO MDR WAS REQUIRED. ON 11/18/2010, THE MANUFACTURER RECEIVED THE PDM ASSOCIATED WITH THIS COMPLAINT. THE DEVICE WAS INVESTIGATED AND A REGULATORY REPORTING RE-ASSESSMENT WAS PERFORMED - BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT AN MDR IS NOW REQUIRED (BASED ON THE FINDING OF DEBRIS IN THE METER PORT THAT LIKELY CONTRIBUTED TO ERRONEOUS BG READINGS). THE PURPOSE OF THIS "NOTE" IS TO EXPLAIN THE GREATER-THAN-ONE-YEAR TIME LAPSE BETWEEN THE DATE OF EVENTS ((B)(6) 2009) AND THE DATE OF THIS REPORT (11/18/2010).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "INCONSISTENT BG READINGS" WHILE USING THE PDM. HE TESTED HIS BG'S THREE TIMES WITHIN FIVE MINUTES AND RECEIVED READINGS OF 241MG/DL, 361MG/DL AND 205MG/DL IN SUCCESSION. INSULET CUSTOMER SUPPORT ATTEMPTED TO TROUBLESHOOT THE ISSUE WITH THE CUSTOMER AND RECOMMENDED THAT HE TRY USING A BACK-UP METER TO COMPARE BG RESULTS WITH. THE PDM WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L12005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other