BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3803108 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13129
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 09/09/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXERCISED FOR 24 HOURS, WITH NO LOSS OF PRIME WARNINGS DUPLICATED. THE FORCE SENSOR CALIBRATION CHECK WAS FOUND TO BE WITHIN SPECIFICATIONS. THE REPORTED EVENT WAS NOT DUPLICATED DURING THE ANALYSIS, DURING WHICH THE PUMP OPERATED ACCORDING TO SPECIFICATIONS. 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 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 PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PATIENT HAD RECURRING LOSS OF PRIME ALERTS WITH MULTIPLE CARTRIDGES FROM DIFFERENT BOXES. THE REPORTER STATED THAT THERE WAS NO SUDDEN CHANGE IN FORCE OR TEMPERATURE AND THE CARTRIDGE CAP WAS SECURED. REVIEW OF CARTRIDGE USAGE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED.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
    281327 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR