BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2955043 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01671
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HAD SEVERAL LARGE PRIMES RECORDED. PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF PRIME. RAN LOAD STEP WITH A CARTRIDGE SET TO 100 UNITS. AFTER LOAD THE PUMP DISPLAYED 100 UNITS. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATION, LOW. REMOVED PUMP FROM CASE. REMOVED FORCE SENSOR FROM MOTOR ASSEMBLY. FORCE SENSOR PLATE WAS CONTAMINATED WITH A GREEN SUBSTANCE. FORCE SENSOR PLATE RESISTANCE WAS READING OUT OF SPECIFICATION. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FADED AND PINK. REMOVED DISPLAYED AND PLACED NEW GOOD DISPLAY IN AND NEW DISPLAY CONTRAST RETURNED TO NORMAL. THE INTERNAL BATTERY WAS CORRODED. 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 PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CONTAMINATED FORCE SENSOR, A FORCE SENSOR OUT OF CALIBRATION, CORROSION AND FAILURE OF THE INTERNAL BATTERY. 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
    59175 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR