BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190660 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09016
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    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

    SUBMITTED: 06/26/2013, DEVICE EVALUATION: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY SHOWED ONLY NORMAL USAGE ALARMS AND WARNINGS. ON TESTING, THE PUMP POWERED ON NORMALLY. THE DISPLAY WAS NOTED TO BE DIM AND DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP, WHICH ILLUMINATED PROPERLY WITHOUT DISCOLORATION. THE PUMP DID NOT DETECT THE CARTRIDGE DURING THE LOAD STEP AND EMITTED THE APPROPRIATE LOAD STEP WARNING. THE FORCE SENSOR CALIBRATION WAS NOTED TO BE OUT OF SPECIFICATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED CONTAMINATION ON THE FORCE SENSOR ASSEMBLY. THE CARTRIDGE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECT WAS NOTED. A LEAK TEST, FILL TEST AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TEST FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. RECALL #2531779-03-24-2010-003-R.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: THE DISPLAY WAS DIM AND DISCOLORED. THE FORCE SENSOR ASSEMBLY HAD CONTAMINATION ON IT AND WAS OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291570 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR