BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3951990 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21053
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE CS (B)(4) WAS VERIFIED IN THE BLACK BOX AND HISTORY. A CS (B)(4) WAS RECEIVED DURING INVESTIGATION. INVESTIGATORS WERE UNABLE TO COMPLETE 24 HOUR TEST DUE TO CS ALARM. INVESTIGATORS RELOADED SOFTWARE AND ABLE TO RETEST PUMP AND ABLE TO COMPLETE PREVIOUSLY FAILED 24 HOUR TEST. OPENED PUMP AND REMOVED FROM CASE. NO FURTHER MOISTURE OR DEFECTS FOUND. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED CORRUPTED SOFTWARE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431128 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR