BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2202479 · Received August 5, 2011

    Report

    Report Number
    3004464228-2011-00399
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 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 WAS RETURNED FOR INVESTIGATION AND NO PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO ERRONEOUS BG READINGS. THE BG METER WAS THOROUGHLY EVALUATED - ALL READINGS TESTED FELL WITHIN SPECIFIED TOLERANCE LIMITS. THE BG METER WAS FOUND TO HAVE PERFORMED AS INTENDED AND WAS FULLY CAPABLE OF PROVIDING ACCURATE READINGS. ALL OTHER TESTING PERFORMED ON THE PDM CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS DESIGNED. BASED ON INVESTIGATION RESULTS, THERE IS NO INDICATION OF ANY PDM FAILURE THAT WOULD HAVE CAUSED DISCREPANT READINGS WHEN COMPARED TO READINGS FROM THE EMS' BG METER. NO PROBLEMS WERE FOUND. NO INTERNAL CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS REPORT AS NO PDM FAILURE MODE WAS FOUND. THE DEVICE PERFORMED AS DESIGNED WITHOUT ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, "SINCE THE SUMMER HAS STARTED SHE HAS BEEN HAVING PROBLEMS WITH RUNNING VERY LOW" (BG LEVELS). SHE "WAS FOUND UNRESPONSIVE BY HER AUNT"; THE AUNT HAD GIVEN HER "KARO SYRUP AND ORANGE JUICE." EMS WAS CALLED, WHO "TOOK ABOUT ONE HOUR OF GIVING HER D50 DRIP"; HER BG LEVEL AT THIS TIME WAS 115 MG/DL (WITH THE EMS' METER). ANOTHER BG READING WAS TAKEN (WITH THE PDM), WHICH READ 60 MG/DL. (THE LENGTH OF TIME BETWEEN METER READINGS IS UNK). THE CUSTOMER DID NOT END UP GOING TO THE HOSP. THE PDM WILL BE RETURNED FOR EVAL.

    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 27 YR Required Intervention