BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3890670 · Received June 24, 2014

    Report

    Report Number
    2531779-2014-18080
    Event Type
    Malfunction
    Date Received
    June 24, 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
    TX, 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 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA FOR THE EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. DURING TESTING, THE PUMP COMPLETED THE REWIND, LOAD, PRIME SEQUENCE AND WAS EXERCISED FOR 24 HOURS SUCCESSFULLY. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN THE REQUIRED RANGE. THE COMPLAINT OF AN INACCURATE DELIVERY ISSUE WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION BECAUSE THE PUMP INFORMATION FOR THE EVENT DATE HAD BEEN OVERWRITTEN. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INACCURATE DELIVERY) ISSUE. IT WAS ALLEGED THAT THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE BELOW 70 MG/DL BUT ABOVE 40 MG/DL, WHICH DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE. 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
    367696 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR