BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1933808 · Received December 11, 2010

    Report

    Report Number
    3004464228-2010-01435
    Event Type
    Injury
    Date Received
    December 11, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 19, 2010
    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 AND EVALUATED. THERE WAS NO EVIDENCE OF ANY MALFUNCTION OR PRODUCT CONDITION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S REPORTED DISCREPANT BG READINGS. THE BG METER WAS THOROUGHLY TESTED AND WAS FOUND TO HAVE FUNCTIONED AS INTENDED - ALL READINGS WERE WITHIN SPECIFIED TOLERANCE LIMITS. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. IT ALSO SUGGESTS THAT THE PT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF EMERGENCY. NO TEST STRIPS WERE IDENTIFIED BY THE CUSTOMER, THEREFORE, NO COMPARATIVE TESTING COULD BE PERFORMED ON THE CUSTOMER'S STRIPS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD "PASSED OUT SEVERAL TIMES DUE TO THE BG METER READING 70 POINTS HIGHER THAN SHE ACTUALLY IS." SHE HAD GONE TO SEE A DOCTOR WHO'S NURSE CHECKED HER BG READING "WITHIN MINUTES" OF HER READINGS BEING CHECKED WITH THE PDM: THERE WAS A 70 POINT DISCREPANCY BETWEEN THE TWO METERS. FOR THIS REASON, HER DOCTOR CONCLUDED THAT ERRONEOUS BG READINGS FROM THE PDM ARE "THE REASON THE PT IS RUNNING SO LOW", CAUSING HER TO PASS OUT. 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 L12072

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention