BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3962812 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21646
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION FOUND THAT ON (B)(6) 2014, THE BLACK BOX RECORDED TWO ¿LOSS OF PRIME¿ WARNINGS DUE TO A NON-ZERO LOW FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS AT A 1 UNIT/HOUR RATE WITH NO ¿LOSS OF PRIME¿ WARNINGS OR OTHER ERRORS OCCURING. THE PUMP'S FORCE SENSOR FAILED A CALIBRATION TEST. THE FORCE SENSOR RESISTANCE WAS TESTED AND FOUND TO BE WITHIN THE APPROPRIATE RANGE. THE PATIENT'S COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE LOSS OF PRIME ALLEGATION, THE BATTERY CAP WAS DAMAGED AND THE THREADS WERE STRIPPED SO A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441912 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR