BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120268 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27564
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 12/01/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/13/2014 WITH THE FOLLOWING FINDINGS: THE U-GROOVE WAS CRACKED ON THE PUMP AND THE BATTERY COMPARTMENT WAS ALSO CRACKED. THE THREADS ON THE BATTERY CAP WERE DAMAGED. THERE WAS EVIDENCE OF MOISTURE EVIDENT INSIDE OF BATTERY COMPARTMENT. THE PUMP FAILED LEAK TEST DUE TO THE BATTERY COMPARTMENT CRACKS. THERE WAS NO OTHER EVIDENCE OF MOISTURE PRESENT INSIDE OF BATTERY COMPARTMENT. UNRELATED TO THE BATTERY COMPARTMENT, WHEN THE PUMP WAS BOOTED THE DISPLAY IS A DIM RED COLOR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. 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
    601979 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR