BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801421 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13016
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND ANY RELATED WARNINGS. THE BATTERY COMPARTMENT AND CAP WERE BOTH UNDAMAGED WITH NO EVIDENCE OF MOISTURE INTRUSION. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE PUMP CASING WAS OPENED AND NO INTERNAL DEFECTS TO THE POWER CIRCUIT OR EVIDENCE OF MOISTURE INTRUSION WERE FOUND. THE INVESTIGATION WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED PUMP OVERHEATING ISSUE.

    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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP AND THE BATTERY WERE HOT TO THE TOUCH. THE PATIENT STATED THAT THERE WAS NO LOSS OF POWER AND THERE WAS NO DAMAGE OR EVIDENCE OF MOISTURE INTRUSION IN THE PUMP. THE PATIENT DENIED ANY INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    279421 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR