BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780878 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11821
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP WAS FURTHER EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREADS TO THE CASE SEAL. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM/FADING/DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD COVER WAS TORN AT THE OK BUTTON. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED/DAMAGED. 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
    260197 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR