BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831373 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14736
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Report Date
    May 5, 2014
    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 HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2014 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. A REVIEW OF THE PUMP BLACK BOX DATA INDICATED NO RECORDED DATA FROM THE EVENT DATE. THE AVAILABLE BLACK BOX DATA CONTAINED A LOSS OF PRIME ASSOCIATED WITH A LOW, NON-ZERO FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DUPLICATED LOSS OF PRIME WARNINGS. THE FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A LOAD STEP MALFUNCTION ISSUE. THE REPORTER WAS UNWILLING TO COMPLETE TROUBLESHOOTING AND 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
    309608 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR