BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4090941 · Received September 15, 2014

    Report

    Report Number
    2531779-2014-26322
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/08/2015 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX FOUND NO EVIDENCE OF RELATED ISSUES; DATA RELEVANT TO THE ALLEGED ISSUE WAS OVERWRITTEN DUE TO CONTINUED PUMP USE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP¿S FORCE SENSOR CALIBRATION WAS WITHIN SPECIFICATION. NO DAMAGE OR DEFECT WAS FOUND TO THE PUMP¿S INTERNAL COMPONENTS. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A LOSS OF PRIME ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING WAS UNABLE TO BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED. 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
    568985 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR