BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4250582 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32655
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 01/29/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/10/2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT.THE BLACK BOX SHOWS AN UNCONFIRMED REPLACE CARTRIDGE ON 10/28/2014; ALARM WAS UNCONFIRMED FOR 5HRS 49MINS. THE UNCONFIRMED ALARM BYPASSED THE LOW BATTERY WARNING RESULTING IN AN EAW-128 REPLACE BATTERY ALARM AT 06:36. PUMP WAS EXERCISED FOR 24HRS WITH NO EAW¿S OCCURRING. BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED; TEST CAPS USED TO COMPLETE TESTING. A LOW BATTERY WARNING WAS REPRODUCED ON THE BENCH FOR TESTING PURPOSES; THE WARNING WAS RECORDED AT THE CORRECT VOLTAGE THRESHOLD AND WAS ACCURATELY RECORDED IN THE PUMP HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. REPORTER WAS CONCERNED THAT NO LOW BATTERY WARNING APPEARED IN PUMP HISTORY AND PUMP DID NOT ALARM THAT THERE IS A LOW BATTERY BEFORE PUMP SHUT OFF. 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
    738685 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR