BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834078 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14864
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/12/2014. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/09/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF THE BLACK BOX DATA DID NOT FIND ANY UNEXPLAINED PUMP REBOOT OCCURRENCES. INVESTIGATION FOUND THAT THE THREADS ON THE BATTERY CAP WERE STRIPPED AND THE BATTERY COMPARTMENT WAS CRACKED IN THE THREADS AREA. EVIDENCE OF MOISTURE INTRUSION WAS OBSERVED IN THE BATTERY COMPARTMENT. A LEAK TEST SHOWED THAT THE BATTERY COMPARTMENT WAS LEAKING WHERE THE CRACK WAS LOCATED. THE RETURNED BATTERY CAP WAS UNABLE TO TIGHTEN PROPERLY BUT WAS TIGHTENED ENOUGH TO ALLOW THE PUMP TO POWER ON. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE PUMP CASING WAS OPENED AND NO ADDITIONAL EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP. INVESTIGATION WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED POWER ISSUE. UNRELATED TO THE REPORTED POWER ISSUE, IT WAS OBSERVED THAT THE AUDIO BOLUS BUTTON COVER WAS TORN BUT THE BUTTON RESPONDED PROPERLY.

    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 POWER (MOISTURE INGRESS) ISSUE. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE AND THERE WAS EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THE CAP WAS ABLE TO TIGHTEN PROPERLY. 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
    311486 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR