BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2902135 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00383
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/09/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/11/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE BLACK BOX HISTORY SHOWED NO EVIDENCE OF PUMP REBOOTS. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. A NEW TEST BATTERY CAP ATTACHED TO THE PUMP PROPERLY WITH NO VISIBLE YELLOW O-RING SHOWING. DURING EVALUATION, THE PUMP WAS EXERCISED FOR 24 HOUR DURATION TEST USING THE TEST BATTERY CAP WITH NO POWER INTERRUPTIONS. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF INTERMITTENT CONNECTIONS OR MOISTURE CONTAMINATION WERE FOUND INSIDE THE PUMP. THE COMPLAINT OF AN INTERMITTENT POWER ISSUE WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION AND NO DEFECT WAS 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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)2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A POTENTIAL INTERMITTENT POWER ISSUE. THE PUMP WAS UNAVAILABLE FOR TROUBLESHOOTING AT THE TIME OF THE INITIAL CONTACT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED. 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
    8899 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR