BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3932366 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19915
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2014 WITH THE FOLLOWING FINDINGS: UNABLE TO DOWNLOAD BLACK BOX. PUMP WOULD NOT POWER ON. CORROSION IN BATTERY COMPARTMENT AND ON CAP SPRING. BATTERY COMPARTMENT CRACKED FROM THREADS TO GRIP. OPENED PUMP AND REMOVED FROM CASE. CORROSION ALONG BATTERY CYLINDER. UNABLE TO TEST ALL STEPS DUE TO NO POWER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP STARTED CONTINUOUSLY VIBRATING YESTERDAY AND WOULD NOT STOP; THERE WAS NO ALARM ON SCREEN, NO WARNING, NO ALERTS. PATIENT DISCONNECTED AT SKIN SITE AND DID AN AIR BOLUS TO SEE IT THIS WOULD HELP; AFTER THE AIR BOLUS PUMP STOPPED VIBRATING BUT CONTINUED TO MAKE A VIBRATION THAT IS FELT AND HEARD EACH TIME THE BASAL WAS DELIVERED AND HAS NOT STOPPED SINCE THAT TIME; REVIEW OF ALARMS SHOWS LOW CARTRIDGE FOR (B)(6) 2014 AND (B)(6) 2014, NO OTHERS; REVIEW OF SOUNDS SHOWS PATIENT HAS EVERYTHING SET TO HIGH WITH TEMPORARY BASAL SET TO OFF AND REMOTE BOLUS SET TO VIBRATION; PATIENT INFREQUENTLY USES REMOTE BOLUS. THERE IS NO ALLEGATION OF AN ADVERSE EVENT. 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
    411285 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR