BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132221 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07163
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 20-FEB-2018. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05-FEB-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX SHOWED NO EVIDENCE OF CS 163 NO CARTRIDGE DETECTED WARNINGS. DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS WITH NO WARNINGS OR LOAD STEP ISSUES OCCURRING. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN REQUIRED SPECIFICATION. A LOAD STEP MALFUNCTION WAS NOT DUPLICATED DURING INVESTIGATION. THE PUMP WAS OPENED AND NO DAMAGE OR DEFECT WAS FOUND. THE COMPLAINT OF A LOAD STEP MALFUNCTION ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED A DIM, DISCOLORED DISPLAY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. REPORTEDLY, THE PUMP WAS NOT DETECTING THE CARTRIDGE DURING THE LOAD STEP AND WAS NOT READING THE AMOUNT OF INSULIN IN THE CARTRIDGE CORRECTLY. 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
    235891 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1