BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4001577 · Received August 12, 2014

    Report

    Report Number
    2531779-2014-23146
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    August 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/30/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE GRIP PAD TO THE CASE SEAL; THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED EVENT. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS UNDAMAGED AND ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THE PUMP FAILED A LEAK TEST DUE TO THE AFOREMENTIONED BATTERY COMPARTMENT DAMAGE. THE PUMP CASE WAS REMOVED, AND CORROSION WAS FOUND ON VARIOUS INTERNAL COMPONENTS: THE REPORTED EVENT WAS DUPLICATED. UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. 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 CASING/CONDITION (MOISTURE INGRESS) ISSUE. REPORTEDLY, EVIDENCE OF MOISTURE INGRESS WAS OBSERVED BEHIND THE DISPLAY LENS; NO EVIDENCE OF DAMAGE TO THE PUMP WAS OBSERVED. 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
    480938 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR