BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 792119 · Received December 4, 2006

    Report

    Report Number
    2939301-2006-01647
    Event Type
    Injury
    Date Received
    December 4, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 29, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON OCTOBER 31, 2006, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONE TOUCH ULTRA WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS/NORMAL READINGS AND TO THE DOCTOR'S DEVICE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT ON NOVEMBER 29, 2006 TO OBTAIN/VERIFY THE FOLLOWING INFORMATION. FOR ABOUT 2-3 WEEKS PRIOR TO CONTACTING LIFESCAN ON OCTOBER 31, 2006, THE PATIENT REPORTEDLY WAS GETTING "HIGH" METER READINGS SUCH AS "210-215 MG/DL" WHILE EXPECTING METER READINGS IN THE 120-150 MG/DL RANGE. SHE USUALLY TESTS ABOUT TWICE A WEEK BUT WOULD TEST TWICE A DAY IF HER METER READS ABOVE 180 MG/DL. WHEN SHE OBTAINED METER READINGS ABOVE 180 MG/DL, SHE WOULD TAKE 1 PILL OF GLUCOPHAGE, WAS REPORTEDLY GETTING "FAINTING SPELLS," DIZZINESS, SWEATING, AND SHAKING AT UNSPECIFIED TIMES, AND ADMINISTERED SELF CARE WITH "SWEETS." SHE TESTED DURING HER SYMPTOMS AND REPORTEDLY WAS STILL GETTING READINGS AROUND "210-215 MG/DL." ON OCTOBER 31, 2006 MORNING, THE PATIENT OBTAINED A "198 MG/DL" ON HER METER AT HOME. SHE WAS CONCERNED WITH HER HIGH METER READINGS AND HER RECENT "FAINT SPELLS" SO SHE WENT TO THE HOSPITAL. WITHIN 10-15 MINUTES LATER, SHE OBTAINED A "108 MG/DL" ON THE HOSPITAL'S DEVICE. SHE WAS TOLD THAT HER BLOOD SUGAR LEVELS WERE "NORMAL" BUT WAS ADVISED TO STOP TAKING HER GLUCOPHAGE. THE CUSTOMER CARE ADVOCATE (CCA) VERIFIED THAT THE METER WAS CORRECTLY SET TO "MG/DL", AN APPROVED SAMPLE SOURCE WAS USED, AND THE CORRECT TECHNIQUE WAS USED TO CLEAN THE PUNCTURE SITE; HOWEVER, THE CCA DISCOVERED THAT THE METER WAS MISCODED. THE PATIENT WAS UNABLE TO CONFIRM IF THE TEST STRIPS WERE OPENED PAST DISCARD DATE. EVEN THOUGH THE "198 AND 108 MG/DL" BLOOD GLUCOSE RESULTS EXCEEDED THE EXPECTED VALUE OF <=30% AND/OR<=30 MG/DL, THE METER WAS MISCODED WHICH CAN CONTRIBUTE TO INACCURATE METER READINGS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED RELATIVELY HIGH METER READINGS, TOOK HER ORAL MEDICATIONS BASED ON HER METER READINGS, AND DEVELOPED SYMPTOMS THAT WOULD SUGGEST LOW BLOOD GLUCOSE. WHEN THE PATIENT WAS SYMPTOMATIC, HER METER READINGS DID NOT CORRELATE WITH HER SYMPTOMS. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2566057

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R