BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200141 · Received August 10, 2011

    Report

    Report Number
    2531779-2011-05764
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 BATTERY COMPARTMENT WAS FOUND TO BE CRACKED; THERE WAS CORROSION PRESENT INSIDE THE BATTERY COMPARTMENT. THE BATTERY WAS RETURNED WITH THE PUMP AND CORROSION WAS FOUND ON THE POSITIVE SIDE OF THE BATTERY. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND THE PUMP ELECTRICAL CURRENT DRAWS WERE NORMAL. A REVIEW OF THE PUMP ALARM HISTORY SHOWED THAT THERE WERE SEVERAL "LOW BATTERY" WARNINGS. A REVIEW OF THE BLACK BOX SHOWED THAT THE PUMP ELECTRICAL CURRENT DROPPED BY 10 TO 20 MA DURING DELIVERY ON THE REPORTED EVENT DATE. THE PUMP WAS OPENED AND NO INTERNAL MOISTURE DAMAGE WAS OBSERVED. NO PUMP OVERHEATING WAS DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS TO REPORT THAT THE PUMP FELT WARM TO THE TOUCH. THE PATIENT DENIED ANY INJURY OR BURNS TO THE SKIN. AT THE TIME OF THE CALL, THE PATIENT CLAIMED WHEN SHE REMOVED THE BATTERY FROM THE PUMP, SHE NOTICED CORROSION IN THE BATTERY COMPARTMENT. THE PATIENT STATED IT APPEARED AS IF THE BATTERY HAD EXPLODED. PRIOR TO WHEN THE ALLEGED ISSUE STARTED, THE PATIENT MENTIONED SHE WENT SWIMMING WITH THE PUMP IN THE OCEAN THE DAY PRIOR. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 39 YR