BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2970416 · Received February 20, 2013

    Report

    Report Number
    2531779-2013-01958
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED REBOOTING HAD OCCURRED. VISUAL INSPECTION REVEALED NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP. THE PUMP POWERED ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) /2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP WAS FOUND ON THE VERIFY SCREEN. 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
    74675 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR