BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882498 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14948
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE DAILY INSULIN TOTALS WERE REVIEWED AND THEY WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES, SHOWING DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. THE ALARM HISTORY AND BLACK BOX CONTAIN NO ERRORS OR ALARMS RELATED TO THE COMPLAINT. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012, THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS TO REPORT THAT FOR TWO DAYS THE PATIENT HAD OBTAINED ELEVATED BLOOD GLUCOSE READINGS RANGING FROM 240 MG/DL TO 480 MG/DL WHEN HER TARGET VALUE IS BELOW 180 MG/DL. DURING THIS TIME PERIOD THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PUMP WAS NOT AVAILABLE AT THE TIME OF THE CALL TO CUSTOMER SUPPORT, THEREFORE NO PUMP TROUBLESHOOTING WAS PERFORMED. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE REPORTER TO OBTAIN FURTHER INFORMATION; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED PUMP. THE PATIENT'S BLOOD GLUCOSE LEVELS WITHOUT SYMPTOMS WERE NOT INDICATIVE OF SEVERE INJURY AS DEFINED BY ANIMAS, AND THE PATIENT DID NOT RECEIVE ANY MEDICAL ATTENTION. HOWEVER, AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR