BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230382 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11045
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 10/02/2013 CORRECTION.THE DATE OF EVALUATION BY PRODUCT ANALYSIS SHOULD REFLECT 09/10/2013.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 10/02/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX HISTORY SHOWED THAT LOSS OF PRIME WARNINGS HAD OCCURRED ASSOCIATED WITH LOW, NON-ZERO FORCE. THE PUMP SUCCESSFULLY PERFORMED THE REWIND, LOAD, AND PRIME STEPS AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSING PRIME. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND CONFIRMED THAT THE FORCE SENSOR WAS WITHIN CALIBRATION. THE PUMP WAS OPENED AND THE FORCE SENSOR WAS INSPECTED WITH NO DEFECTS IDENTIFIED. THE REPORTED LOSS OF PRIME ISSUE WAS UNABLE TO BE DUPLICATED DURING TESTING. 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 (UNEXPLAINED LOSS OF PRIME) ISSUE. 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
    329038 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR