BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4002189 · Received August 12, 2014

    Report

    Report Number
    2531779-2014-23169
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    August 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: THE PUMP FAILED A LEAK TEST DUE TO A LEAK AT THE BATTERY COMPARTMENT, AND EVIDENCE OF MOISTURE INGRESS WAS OBSERVED INSIDE OF THE BATTERY COMPARTMENT; THE REPORTED EVENT WAS DUPLICATED. THE BATTERY COMPARTMENT WAS CRACKED, WHICH DIRECTLY CAUSED THE MOISTURE INGRESS EVENT. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS OBSERVED. A BATTERY CAP WAS NOT RETURNED WITH THE DEVICE; A TEST BATTERY CAP WAS USED DURING ALL STEPS OF THE ANALYSIS.

    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 CASING/CONDITION (MOISTURE INGRESS) ISSUE. REPORTEDLY, EVIDENCE OF MOISTURE INGRESS WAS OBSERVED IN THE BATTERY COMPARTMENT; 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
    480154 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR