BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221273 · Received August 17, 2011

    Report

    Report Number
    3004464228-2011-00403
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PDM WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN ERRONEOUS OR FALSE-HIGH BG READINGS. DESPITE THE REPORT OF A PDM "ERROR", NO SPECIFIC ISSUE WAS CITED; NO ERROR CODE REFERENCE NUMBER WAS PROVIDED. IT IS UNKNOWN WHAT CONDITION HAD OCCURRED THAT REQUIRED THE PDM TO BE RESET. THE CUSTOMER STATED THAT SHE WAS "NOT ABLE TO CALL PRODUCT SUPPORT FOR INFORMATION ON RESETTING THE PDM." THE OMNIPOD USER GUIDE (SECTION 6) CONTAINS INSTRUCTIONS ON HOW "TO RESET THE PDM." IT IS UNKNOWN WHETHER THE CUSTOMER HAD ATTEMPTED TO FOLLOW THESE INSTRUCTIONS TO PERFORM A MANUAL RESET OF THE PDM PRIOR TO CALLING PRODUCT SUPPORT. BASED ON THE INFORMATION PROVIDED IN THE REPORT AND IN THE ABSENCE OF A DEVICE EVALUATION, WE ARE UNABLE TO DETERMINE WHETHER THE PDM MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS RESULTING IN HOSPITALIZATION. NO CONCLUSION CAN BE DRAWN. NO LOT NUMBER WAS PROVIDED. A REVIEW OF LOT QUALIFICATION RECORDS WAS THEREFORE UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS HOSPITALIZED BECAUSE HER "PDM HAD AN ERROR" AND SHE WAS UNABLE TO CALL INSULET PRODUCT SUPPORT "FOR INFORMATION ON RESETTING" THE DEVICE. AS A RESULT, SHE EXPERIENCED HIGH BG LEVELS; HER BG READING UPON ARRIVING AT THE HOSPITAL WAS 564MG/DL. SHE WAS PLACED ON AN IV INSULIN DRIP - FURTHER INFORMATION ABOUT HER CONDITION AFTER TREATMENT WAS NOT PROVIDED. NO SPECIFIC ISSUE WITH THE PDM WAS CITED. NO PRODUCT 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 13100-2B UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization