BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 766395 · Received September 29, 2006

    Report

    Report Number
    2939301-2006-01362
    Event Type
    Injury
    Date Received
    September 29, 2006
    Date of Event
    September 25, 2006
    Report Date
    September 26, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY REPORTER/WIFE CONTACTED LIFESCAN (LFS) IN 2006 ALLEGING THAT THE PATIENT'S TEST STRIPS FAILED USIING THE CONTROL SOLUTION ON HIS ONE TOUCH ULTRA METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER TO THE PATIENT SINCE THE USER COULD NOT BE REACHED TO OBTAIN FURTHER CLINICAL INFORMATION. MAS ALSO LISTENED TOTHE RECORDED CALL AND OBTAINED THE FOLLOWING INFORMATION: RECENTLY THE PATIENT HAD OBTAINED ELEVATED READINGS. IN THE MORNING, HIS READINGS RECENTLY HAVE BEEN OVER 200-300 MG/DL AND IN THE AFTERNOON, HIS READINGS WERE BETWEEN 150-160 MG/DL. THOSE READINGS ARE UNUSUALLY HIGH FOR HIM IN THE MORNINGS AND IN THE AFTERNOONS. IN 2006 THE PATIENT WENT TO THE PHYSICIAN'S OFFICE DUE TO THE ELEVATED READINGS ON HIS METER. THE PATIENT HAD A SCHEDULE APPOINTMENT AT 4:15 PM; HOWEVER, WAS NOT SEEN TILL 6:00 PM. WHILE IN THE LOBBY AT THE PHYSICIAN'S OFFICE, THE PATIENT DEVELOPED SYMPTOMS, WHICH CONSISTED OF FEELING SHAKY, SWEATY, AND WEAK. WIFE TREATED HIM WITH A PEPPERMINT CANDY; HOWEVER, HE CONTINUED TO EXPERIENCE THE SYMPTOMS. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE PRIOR TO EXPERIENCING SYMPTOMS AND THERE IS NO INFORMATION ON WHEN HE TOOK HIS LAST BLOOD GLUCOSE READNG PRIOR TO VISITING THE PHYSICIAN. THE READING ON THE PHYSICIAN'S METER WAS 85 MG/DL AT 6:00 PM AND HE DID NOT RECEIVE ANY MEDICAL TREATMENT. WHEN THE PATIENT ARRIVED AT HOME HE TESTED HIS BLOOD GLUCOSE ON THE LFS METER AND THE READING WAS 98 MG/DL AN HOUR LATER. THE PATIENT STILL EXPERIENCED THE SYMPTOMS AND THEN ATE HIS DINNER. THERE IS NO INFORMATION ON WHETHER HE FELT BETTER AFTER EATING DINNER. IN 2006 THE REPORTER TOOK THE PATIENT'S METER TO THE DIABETIC CLINIC AND RAN A QUALITY CONTROL TEST AND THE TEST STRIPS FELL OUT OF RANGE. THE CONTROL READING WAS 142. CCA HAD THE PATIENT RUN A CONTROL RANGE AND OBTAINED A 143. THE CONTROL RANGE ON THE VIAL OF TEST STRIP WAS (102-135). THE METER WS CODED PROPERLY (CODE 23). THE TEST STRIPS WERE STORED PROPERLY AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WS CORRECT. THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (UOM). CCA SENT THE PATIENT A REPLACEMENT METER AND CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S EXACT BLOOD GLUCOSE READINGS IN 2006 AND WHETHER THE PATIENT FELT BETTER AFTER EATING DINNER. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OTAINED ELEVATED READINGS FOR SOME TME AND LATER HAD SYMPTOMS AT THE PHYSICIAN'S OFFICE. AFTR TREATMENT, HIS BLOOD GLUCOSE WAS 85 MG/DL. TEST STRIPS ALSO FAILED USING THE CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2635557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R