BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4252431 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32726
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/19/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOWED NO EVIDENCE OF ANY COMMUNICATION ALARMS. THERE WERE SEVERAL LOSS OF PRIME WARNINGS RELATED TO THE PUMP NOT BEING PRIMED AFTER POWERING ON OBSERVED ON (B)(6) 2014. THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS BEING DUPLICATED. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE PRINTED CIRCUIT BOARD FOUND.

    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 THAT THERE WAS A CALL SERVICE ALARM RELATING TO COMMUNICATION. THE REPORTER STATED THAT THE CALL SERVICE ALARM COULD NOT BE FOUND IN THE DEVICE'S HISTORY. 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
    737085 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR