BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4000934 · Received August 12, 2014

    Report

    Report Number
    2531779-2014-23086
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    August 1, 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 10/15/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/01/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF PUMP REBOOT IN THE BLACK BOX. THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE COVER AND BUMPER PAD. THERE WAS NO DAMAGE FOUND TO THE RETURNED BATTERY CAP AND IT'S MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE RETURNED BATTERY CAP FULLY ATTACHED TO THE PUMP WITH NO YELLOW O RING SHOWING. NO POWER INTERRUPTIONS WERE DUPLICATED DURING A 24 HOUR DURATION TEST USING THE RETURNED BATTERY CAP. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT. THE INITIAL COMPLAINT COULD NOT BE DUPLICATED WITH INVESTIGATION. UNRELATED TO THE ALLEGATION OF A POWER INTERRUPTIONS, THE DISPLAY SCREEN WAS OBSERVED TO HAVE A PINKISH CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. REPORTEDLY, THE POWER ISSUE WAS OCCURRING DURING, OR IMMEDIATELY AFTER, A BATTERY CHANGE. 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
    480419 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR