BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2170557 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05087
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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) 2011 WITH THE FOLLOWING FINDINGS: THE HOT PUMP COMPLAINT COULD NOT BE INVESTIGATED DUE TO MOISTURE DAMAGE IN THE PUMP. THE PUMP WAS FOUND TO POWER ON WITH AUDIBLE BEEPS, BUT THE DISPLAY REMAINED BLANK AND THE VIBRATION FEATURE WAS NOT FUNCTIONAL. APPROPRIATE TESTING COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN 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

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED OVERHEATING ISSUE WITH THE ANIMAS PUMP. REPORTEDLY, THE BATTERY COMPARTMENT FELT HOT WHEN THE PATIENT REPLACED THE BATTERY. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE HOT BATTERY OR PUMP. THE ANIMAS REPRESENTATIVE NOTED THE BATTERY CAP WAS REPLACED 4 TO 6 MONTHS PRIOR TO THE CALL TO ANIMAS. THE BATTERY CAP IS IN GOOD CONDITION AND FITS SECURELY ON THE PUMP. THERE WAS NO SIGN OF CORROSION ON THE BATTERY COMPARTMENT AND NO EVIDENCE OF PRODUCT MISUSE. THE PRODUCT WAS RETURNED TO ANIMAS FOR INVESTIGATION.

    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 50 YR