BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4171695 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29188
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 11/10/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF A LOAD STEP MALFUNCTION. THE PUMP¿S BLACK BOX DID RECORD OCCLUSION ALARMS AND ATTEMPTS TO PRIME WITH HIGH FORCE. THERE WERE NO LOAD STEP MALFUNCTIONS, OCCLUSIONS OR LOSS OF PRIMES DURING INVESTIGATION. THE FORCE SENSOR CALIBRATION READING WAS IN SPECIFICATIONS. THE LOAD STEP WAS PERFORMED WITH A CARTRIDGE SET TO 100 UNITS. AFTER LOAD STEP, THE PUMP DISPLAYED 100 UNITS. NO DEFECTS WERE FOUND TO ANY OF THE INTERNAL COMPONENTS OF THE PUMP.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE SERIAL NUMBER FOR THIS DEVICE HAS BEEN UPDATED TO (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6).

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS PRIMING THE TUBING DURING THE LOAD STEP. 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
    650426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR