BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033630 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03507
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED LARGE PRIME VOLUMES AND NO LOSS OF CARTRIDGE DETECTION WARNINGS. DURING TESTING, A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY WITHOUT LOSS OF PRIME. INVESTIGATION REVEALED THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR. EVALUATION ALSO REVEALED THE DISPLAY SCREEN WAS DIM/FADED. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED.

    Description of Event or Problem · 1

    THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE DISPLAY SCREEN WAS DIM/FADED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136101 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR