BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3884305 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17614
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/21/2014. DEVICE EVALUATION: THE PUMP HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND RECORD OF LOSS OF PRIME ALERT DUE TO NON-ZERO LOW FORCE. ON INVESTIGATION, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATIONS. BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED PRIME ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATE DURING THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, MULTIPLE LOSS OF PRIME ALERTS OCCURRED WITH CARTRIDGES FROM DIFFERENT BOXES. THE REPORTER WAS ABLE TO COMPLETE PRIME STEP WITH CARTRIDGE CHANGES. IT WAS REPORTED THAT THERE WAS NO SUDDEN CHANGE IN FORCE OR TEMPERATURE AND THE CARTRIDGE CAP WAS SECURED PROPERLY. REVIEW OF CARTRIDGE USE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED. 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
    359891 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR