BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4820258 · Received June 4, 2015

    Report

    Report Number
    2531779-2015-18662
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    May 20, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 08/04/2015-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2015 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED OCCLUSIONS ASSOCIATED WITH HIGH FORCES. DURING TESTING, THE REWIND, LOAD, AND PRIME STEPS WERE COMPLETED SUCCESSFULLY WITH NO DUPLICATED OCCLUSION ALARMS. THE FORCE SENSOR CALIBRATION MEASURED LOW AND WAS NOT WITHIN SPECIFICATIONS. EVIDENCE OF THE COMPLAINT WAS FOUND IN THE BLACK BOX; HOWEVER, THE COMPLAINT WAS NOT DUPLICATED. UNRELATED TO THE COMPLAINT, THE PUMP EMITTED A CS 088 CALL SERVICE ALARM. EVIDENCE OF MOISTURE INGRESS WAS OBSERVED BEHIND THE DISPLAY LENS, AND THE CASING WAS CRACKED NEAR THE DISPLAY. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A LEAK AT THE CRACK IN THE CASING. THE PUMP CASE WAS REMOVED AND DAMAGE DUE TO MOISTURE WAS FOUND ON THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) 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
    362145 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR