BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091536 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03460
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, IT WAS FOUND THAT REBOOTS WERE OBSERVED IN THE PUMP DOWNLOAD HISTORY. THERE WERE NO ALARMS RELATED TO THE COMPLAINT OBSERVED IN THE ALARM HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND CORROSION WAS FOUND ON THE PCB. A CRACKED BATTERY COMPARTMENT WAS FOUND AS WELL AS BATTERY COMPARTMENT LEAK AND MOISTURE IN THE PUMP. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED SELF-REBOOT ISSUE. THERE WAS NO EVIDENCE OF PRODUCT MISUSE OR TRAUMA TO THE DEVICE. THE REPORTER DENIES ANY BLOOD GLUCOSE EXCURSION AS A RESULT OF THE PRODUCT ISSUE.

    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 51 YR