BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4220715 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31231
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: 01/23/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 01/09/2015 WITH THE FOLLOWING FINDINGS:A 'LOSS OF PRIME' WARNING, WHICH WAS DUE TO A NON-ZERO LOW FORCE READING AND CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WAS OBSERVED IN THE BLACK BOX DATA. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO 'LOSS OF PRIME' WARNINGS WERE OBSERVED: THE REPORTED ISSUE WAS NOT DUPLICATED. THE PUMP PASSED A FORCE SENSOR CALIBRATION CHECK. THE PUMP SUCCESSFULLY PERFORMED THE BOLUS AND PRIME SEQUENCE FUNCTIONS. DURING THE ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS. A CARTRIDGE CAP AND BATTERY CAP WERE NOT RETURNED WITH THE PUMP; A TEST CARTRIDGE CAP AND TEST BATTERY CAP WERE USED DURING THE ANALYSIS. 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 PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT A LOSS OF PRIME WARNING OCCURRED 3 OR MORE TIMES WITHIN A 30 DAY PERIOD, DURING WHICH AT LEAST 3 SEPARATE CARTRIDGES FROM 2 SEPARATE BOXES WERE USED. 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
    701404 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR