BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3931168 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19832
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/23/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED NO UNEXPLAINED PUMP REBOOTS OR RELATED ALARMS. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE RETURNED BATTERY CAP SECURED PROPERLY TO THE PUMP, AND A POWER LOSS WAS NOT OBSERVED. THE BATTERY CAP CONTACT DIMENSIONS MEASURED WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED.

    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 POWER (NO POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT A NEW BATTERY WAS INSERTED, BUT THE PUMP WOULD NOT POWER ON APPROPRIATELY. 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
    411323 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR