BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222172 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10331
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/14/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORY WAS REVIEWED AND THERE WAS NO EVIDENCE OF A ¿LOAD STEP MALFUNCTION.¿ ON 06/12/2013, A ¿LOSS OF PRIME¿ OCCURRED AT 16 UNITS, 1.15 UNITS WERE PRIMED, AND THE PUMP STARTED DELIVERY AT 14 UNITS. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY AND WAS PRIMED SUCCESSFULLY WITHOUT ANY ALARMS OCCURRING. THE FORCE SENSOR CALIBRATION WAS WITHIN SPECIFICATION. DURING INVESTIGATION, THE PUMP WAS OPENED AND THE FORCE SENSOR WAS FOUND TO BE INTACT WITH NO INTERMITTENT CONDITIONS. NO DEFECT WAS FOUND. 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. 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. CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER INDICATED THAT THE PUMP WAS DISPENSING LARGE AMOUNTS OF INSULIN DURING THE LOAD STEP. THE REPORTER STATED THAT THE CARTRIDGE WAS FILLED WITH 60 UNITS AND THE LOAD STEP PRIMED OUT INSULIN UNTIL 14 UNITS WERE LEFT. 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
    322561 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR