BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4240780 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32013
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 01/23/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/10/2015 WITH THE FOLLOWING FINDINGS: THERE WAS ONE UNEXPLAINED PUMP REBOOT EVENT OBSERVED IN THE BLACK BOX. THE BATTERY COMPARTMENT WAS CRACKED FROM THREADS TO THE BUMPER PAD AND FROM THE BUMPER PAD TO THE COVER. THE RETURNED BATTERY CAP HAD STRIPPED THREADS AND WAS UNABLE TO FULLY ATTACH TO THE PUMP. PUMP REBOOT EVENTS WERE DUPLICATED WITH THE RETURNED BATTERY CAP. A NEW TEST BATTERY CAP WAS ABLE TO CAREFULLY ATTACH TO THE PUMP. A 24 HOUR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH TEST BATTERY CAP. NO PUMP REBOOTS WERE DUPLICATED. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. UNRELATED TO THE ORIGINAL COMPLAING, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. IT WAS REPORTED THAT THE BATTERY CAP HAD STRIPPED THREADS AND HAD NOT BEEN REPLACED IN OVER THIRTEEN MONTHS. 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
    722538 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR