BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120236 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27507
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/24/2014 WITH THE FOLLOWING FINDINGS: THERE WERE UNEXPLAINED PUMP REBOOT EVENTS OBSERVED IN THE DEVICE'S BLACK BOX ON (B)(6) 2014. THE BATTERY COMPARTMENT IS CRACKED ON THE SIDE NEAR THE THREADS AND CRACKED BETWEEN BUMPER PAD AND COVER. THE RETURNED BATTERY CAP HAD STRIPPED THREADS AND WAS UNABLE TO FULLY ATTACH TO THE PUMP. THE PUMP REBOOT EVENTS WERE DUPLICATED WITH THE RETURNED BATTERY CAP. A NEW TEST BATTERY CAP WAS ABLE TO CAREFULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE 24HR DURATION TESTING. NO POWER INTERRUPTIONS WERE DUPLICATED WITH THE TEST BATTERY CAP. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT FOUND. UNRELATED TO THE POWER ISSUES, THE DISPLAY SCREEN WAS OBSERVED TO HAVE A PINKISH CONTRAST.

    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 THAT THE BATTERY COMPARTMENT OF THE PUMP WAS CRACKED AND THE BATTERY CAP HAD STRIPPED THREADS. THE REPORTER ALLEGED THAT THIS WAS CAUSING AN INTERMITTENT POWER 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
    601372 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR