BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822896 · Received May 21, 2014

    Report

    Report Number
    2531779-2014-14334
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. THE DISPLAY WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/10/2014, ADDITIONAL INFORMATION: THE REPORTER CONTACTED ANIMAS AND PROVIDED THE FOLLOWING INFORMATION REGARDING THE EVENT. REPORTEDLY, THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP AND CONTRAST RESET DID NOT RESOLVE THE DIM DISPLAY ISSUE. THE REPORTER STATED THAT THE SCREENS CANNOT BE READ/MANEUVER SAFELY. NO BLOOD GLUCOSE EXCURSION WAS REPORTED.

    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 DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE. SEVERAL ATTEMPTS BY THE CUSTOMER SUPPORT TO FOLLOW-UP ON THE MATTER WITH THE REPORTER WERE UNSUCCESSFUL. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303906 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR