BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113211 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06429
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PRIME HISTORY RECORDED SEVERAL LARGE PRIMES. ATTEMPTED TO REWIND AND LOAD BUT RECEIVED A CARTRIDGE NOT DETECTED ALARM. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATION, LOW. REMOVED DISPLAY LENS. BOTH THE DISPLAY AND FORCE SENSOR FLEX WERE SECURE. OPENED PUMP. REMOVED FORCE SENSOR FROM MOTOR ASSEMBLY. FORCE SENSOR PLATE WAS CONTAMINATED WITH A GREEN SUBSTANCE. FORCE SENSOR PLATE RESISTANCE READING OUT OF SPECIFICATION. REMOVED PISTON FROM PUMP. INSPECTED FOR EXCESS FLASHING. PISTON MEASURED WITHIN SPECIFICATION. UNRELATED TO COMPLAINT, THE DISPLAY WAS FADED AND PINK. REMOVED DISPLAYED AND PLACED NEW GOOD DISPLAY IN. NEW DISPLAY CONTRAST RETURNED TO NORMAL. 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

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED THE FORCE SENSOR WAS OUT OF CALIBRATION AND CONTAMINATED, AND THE DISPLAY SCREEN WAS DIM AND FADED. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215188 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR