BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213816 · Received August 17, 2011

    Report

    Report Number
    2531779-2011-05965
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    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: NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE BLACK BOX HISTORY. THE BATTERY COMPARTMENT SHOWED NO SIGNS OF DAMAGE. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED DURING TESTING. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 6 HOURS WITHOUT OVERHEATING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP BECAME VERY HOT SHORTLY AFTER RECEIVING A BLOOD GLUCOSE CHECK REMINDER. THE PATIENT DENIED ANY BURNS OR INJURY AS A RESULT. HE STATED THAT HE DID NOT TOUCH THE BATTERY; HIS GIRLFRIEND REPORTEDLY REMOVED THE BATTERY CAP AND LET THE BATTERY DROP OUT OF THE PUMP. THE PATIENT DENIED CORROSION OR WATER IN THE BATTERY COMPARTMENT. HE STATED THAT THE PUMP WAS NOT EXPOSED TO WATER OR MOISTURE. THE PATIENT CONFIRMED THAT THE BATTERY CAP TIGHTENS TO RESISTANCE, AND THERE IS NO STRUCTURAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT. THE PATIENT STATED THAT THE BATTERY CAP HAS NEVER BEEN CHANGED; THE PUMP HAS BEEN IN USE SINCE (B)(6) 2009. THE USER GUIDE INSTRUCTS THE USER TO CHANGE THE BATTERY CAP EVERY SIX MONTHS.

    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 29 YR