BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822407 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14303
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/03/2015 WITH THE FOLLOWING FINDINGS: THE PUMP CASE WAS REMOVED AND NO INTERNAL DAMAGE WAS FOUND; THE MOTOR DRIVE WAS VISUALLY INSPECTED AND NO DEFECTS WERE OBSERVED. THE INVESTIGATION WAS COMPLETED WITH THE RETURNED BATTERY CAP WITH NO RELATED MALFUNCTIONS FOUND. THE BLACK BOX SHOWED NO EVIDENCE OF REWIND ALARMS. THE PUMP WAS ABLE TO PROPERLY REWIND AND PRIME; PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE COMPLAINT. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS FOUND TO BE DIM, FADING, AND REDDISH IN COLOR. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE BUMPER PAD. 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.

    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 MOTOR (REWIND ISSUE) ISSUE. THE REPORTER STATED THAT THE PISTON ROD WAS NOT RETRACTING. 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
    299017 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR