BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801382 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13024
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    FOLLOW-UP # 1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/14/2015 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE AVAILABLE BLACK BOX DATA REVEALED EVIDENCE OF PUMP REBOOTS. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED TO COMPLETE INVESTIGATION. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DUPLICATED LOSS OF POWER OR CALL SERVICE ALARMS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS ALLEGED THAT THE BATTERY EXPLODED WHILE IN THE PUMP, AND THE PUMP LOST POWER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279068 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR