BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3031135 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03443
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. REVIEW OF THE HISTORY SHOWS NO EVIDENCE OF A LOAD STEP MALFUNCTION. SUCCESSFULLY PERFORMED A REWIND, LOAD AND PRIME SEQUENCE WITH NO ISSUES. A CARTRIDGE WITH APPROXIMATELY 120U WAS FILLED AND RECOGNIZED CORRECTLY BY THE PISTON ROD. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATION. REMOVED THE PUMP COVER; FORCE SENSOR PINS ARE SEATED AND INTACT. NO EVIDENCE OR INTERNAL MOISTURE OR DAMAGE WAS OBSERVED AND NO EVIDENCE OF DEBRIS OBSERVED IN THE CARTRIDGE COMPARTMENT. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. 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
    133541 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR