BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4191399 · Received October 21, 2014

    Report

    Report Number
    2531779-2014-29870
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/14/2014. DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED TO ANIMAS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A FORCE TEST WAS PERFORMED WITH NO ISSUES OR FAILURES FOUND. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 11/24/2014 WITH THE FOLLOWING FINDINGS: THE PUMP¿S BLACK BOX REVIEW SHOWED LOSS OF PRIME WARNINGS ASSOCIATED WITH A LOW NON-ZERO FORCE ON 10/08/2014. AN EZPRIME SEQUENCE AND 24HR DURATION TEST WERE SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE FORCE SENSOR CALIBRATION CHECK SHOWED THAT THE PUMP WAS DETECTING THE CORRECT FORCE. 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 THAT THERE WERE MULTIPLE LOSS OF PRIME WARNINGS WITH DIFFERENT CARTRIDGES. 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
    669073 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR