BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3830014 · Received May 23, 2014

    Report

    Report Number
    2531779-2014-14678
    Event Type
    Malfunction
    Date Received
    May 23, 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
    TX, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/12/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/09/2014 WITH THE FOLLOWING RESULTS:A REVIEW OF THE BLACK BOX SHOWED NO UNEXPLAINABLE REBOOTS. THE PUMP WAS NOT ABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH THE RETURNED BATTERY CAP; THE CAP HAD DAMAGED THREADS AND THE BATTERY COMPARTMENT WAS CRACKED. EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND IN THE BATTERY COMPARTMENT. THE PUMP WAS ABLE TO POWER ON WITH A TEST CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR ALARMS. THE PUMP COVER WAS OPENED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND IN THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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
    308221 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR