BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842614 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13843
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2013 WITH THE FOLLOWING FINDINGS: DUE TO CONTINUED USE OF THE PUMP, THE EVENT DATE WAS OVERWRITTEN IN THE PUMP¿S HISTORY. A REVIEW OF THE DAILY INSULIN DELIVERY TOTALS SHOWED THAT THEY CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. DUE TO AN UNRELATED FAILURE, AN ALARM WAS EMITTED THAT COULD NOT BE CLEARED AND THE PUMP COULD NOT BE ADEQUATELY TESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012, THE PATIENT CONTACTED ANIMAS AND LEFT A MESSAGE THAT THE PUMP WAS NOT WORKING AND HE HAD NOT RECEIVED INSULIN IN OVER A DAY. IT WAS NOTED THAT THE PATIENT COULD NOT REMEMBER ANY OF HIS INFORMATION DUE TO "BLOOD SUGAR ISSUES". NO ADDITIONAL INFORMATION WAS PROVIDED. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO REACH THE PATIENT TO OBTAIN ADDITIONAL INFORMATION AND REVIEW THE SUBJECT PUMP; HOWEVER, WERE UNSUCCESSFUL IN THEIR ATTEMPTS. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE ALLEGED PUMP ISSUE CAUSED AND/OR CONTRIBUTED TO A SEVERE BLOOD GLUCOSE EXCURSION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR