BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4232881 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31770
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 12/20/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF A POWER RELATED ISSUE OBSERVED IN THE BLACK BOX AND PUMP HISTORY DATA. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED IN THE THREAD AREA, AND THE THREADS OF THE RETURNED BATTERY CAP WERE FOUND TO BE STRIPPED; THESE DEVICE FAILURES INDIRECTLY CONTRIBUTED TO THE REPORTED ISSUE. THE RETURNED BATTERY CAP WAS UNABLE TO SECURE TO THE SUSPECT PUMP CASE PER THE INSTRUCTIONS FOR USE (IFU); THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED ISSUE. THE SUSPECT PUMP DISPLAYED AN INTERMITTENT POWER ISSUE WITH THE RETURNED BATTERY CAP INSTALLED: THE REPORTED ISSUE WAS DUPLICATED. A TEST BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE SUSPECT PUMP CASE PER THE IFU, WAS USED FOR THE REMAINDER OF THE ANALYSIS. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER-RELATED EVENTS WERE OBSERVED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER ISSUE. IN ADDITION, IT WAS REPORTED 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
    713559 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR