BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4141334 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28342
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/16/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM THE TIME OF THE EVENT HAS BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE INFORMATION IN THE BLACK BOX SHOWED NO EVIDENCE OF LOSS OF PRIME. THERE WERE MULTIPLE CALL SERVICE (B)(4) ALARMS OBSERVED IN THE PUMP'S BLACK BOX. THE PUMP ALARMED WITH CALL SERVICE (B)(4) ALARM UPON THE FIRST REWIND ATTEMPT. THE COVER WAS REMOVED AND MOISTURE CORROSION WAS FOUND NO THE PRINTED CIRCUIT BOARD ON THE MOTOR BOOST REGULATOR CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS EMITTING REPEATED LOSS OF PRIME ALARMS WITH MULTIPLE CARTRIDGES. 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
    620001 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR