BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3220979 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10318
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/04/2013, DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) /2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION THE LOAD STEP MALFUNCTION WAS VERIFIED IN THE BLACK BOX. THE BLACK BOX ALSO RECORDED SEVERAL LOSS OF PRIMES BOTH WITH ZERO AND LOW NON-ZERO FORCE. ALSO SEVERAL OCCLUSIONS WERE RECORDED. INVESTIGATORS PERFORMED A PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF PRIME. THE FORCE SENSOR CALIBRATION WAS IN SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE LOAD STEP MALFUNCTION. INVESTIGATORS CONFIRMED ISSUE IN HISTORY BUT WAS NOT ABLE TO REPRODUCE DURING INVESTIGATION. THE DISPLAY WAS FOUND TO BE FADED AND PINK. THE BATTERY COMPARTMENT CRACKED FROM CASE SEAL TO GRIP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. 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
    319711 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR