BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3871785 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16881
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 10, 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 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/13/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO EVIDENCE OF MOTOR ISSUES OCCURRING. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS WITH NO REWIND ISSUES OR ALARMS OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO DEFECTS WERE FOUND TO THE LEAD SCREW OR MOTOR ASSEMBLY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP PAD. THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION FOUND INSIDE THE PUMP. THE COMPLAINT OF THE PUMP NOT COMPLETING THE REWIND STEP WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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 MOTOR (REWIND ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS NOT COMPLETING THE REWIND STEP. 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
    350997 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR