BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3911812 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19011
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 12/01/2014.DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED MULTIPLE CS 088 CALL SERVICE ALARMS ON 06/30/2014. THERE WAS NO EVIDENCE OF ALARMS RELATED TO THE CS 069 CALL SERVICE ALARM OBSERVED IN THE BLACK BOX. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DUPLICATED CALL SERVICE ALARMS. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED ON THE INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE BATTERY AND CARTRIDGE CAPS WERE NOT RETURNED WITH THE PUMP, AND TEST CAPS WERE USED TO COMPLETE THE INVESTIGATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP EMITTED A CALL SERVICE ALARM. 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
    391286 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR