BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834122 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14902
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/17/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/13/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT UNEXPLAINABLE POWER REBOOTS WERE RECORDED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREADS TO THE CASE SEAL. THE RETURNED BATTERY CAP THREADS WERE FOUND TO BE STRIPPED AND THE BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP. POWER LOSSES OCCURRED WITH THE RETURNED BATTERY CAP. A TEST BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. THE PUMP WAS EXERCISED FOR 24 HOURS USING THE TEST BATTERY CAP AND NO POWER LOSSES OCCURRED. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND.

    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 (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP LOST POWER. THE INDICATED BLOOD GLUCOSE (BG) LEVEL GREATER THAN 250 MG/DL BUT LESS THAN 500 MG/DL WITH NO SIGNS OR SYMPTOMS WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA 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
    310344 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR