BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971080 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21958
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 10/02/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: AN INEXPLICABLE REBOOT EVENT, WHICH IS POTENTIALLY INDICATIVE OF THE REPORTED EVENT, WAS OBSERVED IN THE BLACK BOX DATA. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREADS TO THE CASE SEAL, AND THE THREADS OF THE RETURNED BATTERY CAP WERE STRIPPED. THE RETURNED BATTERY CAP WAS UNABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). DURING ANALYSIS, REBOOT EVENTS, DUE TO THE AFOREMENTIONED BATTERY CAP DAMAGE, WERE OBSERVED; THE REPORTED EVENT WAS DUPLICATED. DUE TO THE BATTERY CAP DAMAGE, A TEST BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE PUMP PER THE IFU, WAS USED FOR THE REMAINDER OF THE ANALYSIS. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER RELATED ISSUES WERE OBSERVED. THE DISPLAY SCREEN WAS DISCOLORED. THE BATTERY CAP DAMAGE DIRECTLY CAUSED THE REPORTED EVENT, AND ALL OF THE OTHER DEVICE FAILURES WERE UNRELATED TO THE REPORTED EVENT. 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 BATTERY COMPARTMENT WAS CRACKED. REPORTEDLY, THE PUMP WAS EXPERIENCING A NO-POWER 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
    447887 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR