BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3961458 · Received May 29, 2014

    Report

    Report Number
    3004464228-2014-00734
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 6, 2014
    Report Date
    May 2, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    TIME: (B)(6) 2014 - 7:41PM; BLOOD GLUCOSE (MMOL/L): 15.0 (270 MG/DL) - ATE 90G CARBS; BOLUS (UNITS): 16.50U; 9:04PM; 16.3 (294 MG/DL); 5.20U; (B)(6) 2014 - 3:41AM; 16.2 (292 MG/DL); 8.45U; 9:20AM; 12.6 (227 MG/DL). THE CUSTOMER REPORTED THAT HE COULD SMELL INSULIN, AND THAT WHEN THE POD WAS REMOVED, HE NOTICED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315923 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40840

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR