BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033258 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03489
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/18/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATORS CONFIRMED THE AUTO TIMEOUT FEATURE WAS SET TO 12 HOURS. THE LAST AUTO OFF TIMEOUT PUMP SUSPENDED¿ WAS RECORDED IN THE ALARM HISTORY. THE ALARM HISTORY SHOWS SEVERAL 150 ALARMS, HOWEVER, NONE OF THEM OCCUR WITHIN THE HALF AN HOUR AS MENTIONED IN THE SCRIPTS AND NONE ARE WITHIN A 12 HOUR TIME PERIOD. FOR THE INVESTIGATION THE PUMPS AUTO OFF TIMEOUT FEATURE WAS SET TO 1 HR; NO KEY PRESSES WERE EXECUTED WITHIN THE 1 HR TIME PERIOD. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT OF AUTO OFF PRIOR TO THE PROGRAMMED DURATION PERIOD DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (AUTO OFF) ISSUE. THE PUMP IS REPORTEDLY ENACTING THE AUTO OFF FEATURE SOONER THAT THE PATIENT EXPECTED. 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
    135788 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR