BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4005486 · Received August 13, 2014

    Report

    Report Number
    2531779-2014-23280
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/013/2014 ¿ CORRECTION: NOT RETURNED TO MFR.

    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 # 2 DATE OF SUBMISSION 10/10/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO EVIDENCE OF MOTOR ISSUES WAS RECORDED. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS WITH NO MOTOR ISSUES OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO MOTOR ISSUES OCCURRING. THE PUMP CASE WAS REMOVED AND NO DEFECTS WERE FOUND ON THE MOTOR ASSEMBLY AND LEAD SCREW. THE COMPLAINT THAT THE CARTRIDGE PISTON WAS NOT RETRACTING COMPLETELY DURING THE REWIND STEP WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (MOTOR ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE CARTRIDGE PISTON WAS NOT REWINDING COMPLETELY DURING THE REWIND STEP. 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
    483343 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR