BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200904 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09451
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED MULTIPLE CS 064-0001 ALARMS WITH HIGH FORCE OBSERVED IN THE BLACK BOX DUE TO OCCLUSION DURING PRIME. TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION. INVESTIGATORS PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO ALARMS DUPLICATED. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION, INSPECTED THE MOTOR ASSEMBLY AND TESTED THE INTERNAL MOTOR NO DEFECT FOUND OR NO MOISTURE CORROSION WAS OBSERVED. UNRELATED TO THE COMPLAINT, THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. THE DISPLAY LENS WAS ALSO FOUND TO BE SCRATCHED. UNRELATED TO THE COMPLAINT THE UP AND OK SYMBOLS WERE FOUND TO BE WORN. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303387 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR