BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4220735 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31240
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED PUMP NOT PRIMED WARNINGS. DURING THE LOAD STEP, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE, GIVING A NO CARTRIDGE DETECTED WARNING. THE FORCE SENSOR CALIBRATION DID NOT MEASURE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND TO THE INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS PRIMING THE TUBING DURING THE LOAD STEP. IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE WAS GREATER THAN 250 MG/DL, BUT LESS THAN 500 MG/DL WITH NO SYMPTOMS. THE PATIENT¿S BLOOD GLUCOSE READINGS DO NOT MEET ANIMAS¿ CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701824 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR