BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 4093333 · Received September 16, 2014

    Report

    Report Number
    2939301-2014-24377
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 27, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. DATE OF EVENT: NOT PROVIDED. PT AGE, GENDER, WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRA METER WAS GIVING INACCURATELY HIGH READINGS AND THE ERROR 5 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. THE SMSS CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF ¿GREATER THAN 300 MG/DL¿ ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. THE PATIENT TOOK NO ACTIONS BASED ON THIS READING. THE PATIENT ALSO REPORTED SHE OBTAINED THE ERROR MESSAGE ERROR 5 ON THE REPORTED METER AT THAT TIME. THE PATIENT MANAGES HER DIABETES WITH SET DOSES OF INSULIN. TWO HOURS AFTERWARDS, THE PATIENT EXPERIENCED SYMPTOMS OF ¿LOW BLOOD SUGAR¿ LEVELS; SHE DID NOT PROVIDE HER SPECIFIC SYMPTOMS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT, THE TEST STRIPS WERE CORRECT AND IN GOOD CONDITION AND THE TEST STRIPS COMPLETELY DREW IN THE BLOOD SAMPLE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ERROR MESSAGE AND AN ELEVATED METER READING ON THE REPORTED METER. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571215 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3650581

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening