BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2925544 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-01035
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 02/27/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING THE PUMP FAILED TO POWER ON. THE PUMP HISTORY WAS UNABLE TO BE DOWNLOADED DUE TO THE POWER ISSUE. THE PUMP WAS CONNECTED TO AN EXTERNAL POWER SUPPLY AND FOUND THAT THE CURRENT DRAWS WERE OUTSIDE OF SPECIFICATIONS. THE PUMP WAS OPENED AND THE VOLTAGE REGULATOR WAS FOUND TO HAVE FAILED. UNRELATED TO THE COMPLAINT THE BOLUS BUTTON WAS FOUND TO BE SLIGHTLY LIFTED FROM THE PUMP. THE DAMAGED BUTTON IS OBVIOUS AND DETECTABLE TO THE USER AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE REPORTER ATTEMPTED TO POWER THE PUMP ON WITH MULTIPLE BATTERIES FROM DIFFERENT PACKAGES WITH NO SUCCESS. 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
    30034 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR