BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2211706 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05881
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT MULTIPLE REBOOTS HAD OCCURRED. EVALUATION REVEALED THAT THE BATTERY CAP THREADS WERE STRIPPED, AND THE BATTERY CAP WOULD NOT SECURE PROPERLY TO THE PUMP. THERE WAS NO DAMAGE NOTED TO THE BATTERY COMPARTMENT. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP POWERS ON TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. A STRIPPED BATTERY CAP IS NOT LIKELY TO CAUSE AN ADVERSE EVENT, AS THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP HAD AN INTERMITTENT POWER ISSUE. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP HAD AN INTERMITTENT POWER ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    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 52 YR