BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 791097 · Received November 29, 2006

    Report

    Report Number
    2939301-2006-01631
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    November 24, 2006
    Report Date
    November 27, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    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 NOVEMBER 27, 2006, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH BASED ON A SPECIFIC VIAL OF TEST STRIPS. THE TECHNICAL SERVICE REP CORRESPONDED WITH THE PT ON NOVEMBER 27, 2006, TO OBTAIN/VERIFY INFO. THE PT TESTS HIS BLOOD GLUCOSE TYPICALLY 1-2 TIMES PER DAY. HIS NORMAL/EXPECTED BLOOD GLUCOSE RESULTS ARE ABOUT 5.5-6.5 MMOL/L. THE PT STARTED USING THE REPORTED VIAL OF TEST STRIPS ABOUT 2 WEEKS AGO. THE PT MENTIONED THAT HE TAKES 6 UNITS OF 'HUMALOG" INSULIN BEFORE EACH MEAL. IF HIS BLOOD GLUCOSE IS REALLY HIGH, HE TAKES 7 UNITS INSTEAD. IF HIS BLOOD GLUCOSE IS VERY LOW, HE SKIPS THE INSULIN DOSE. ON NOVEMBER 23 AND 24, 2006, THE PT BELIEVED THAT HE WAS GETTING INACCURATE HIGH RESULTS. HE OBTAINED RESULTS OF "15.7, 13.0, 14.4, AND 9.1 MMOL/L" ON NOVEMBER 23, 2006. ON NOVEMBER 24, 2006, HE REPORTED RESULTS OF OVER "16.0 AND 12.0 MMOL/L." DURING THE TIME OF CONCERN, THE PT DID NOT REPORT ANY SYMPTOMS OF HYPERGLYCEMIA. AT 10:30PM ON NOVERBER 24, 2006, THE PT OBTAINED A BLOOD GLUCOSE RESULT OF OVER 12.0 MMOL/L AND JUST TOOK HIS EVERYDAY NIGHT DOSE OF 15 UNITS "LANTUS" INSULIN BEFORE GOING TO BED. THE NEXT MORNING ON NOVEMBER 25, 2006, THE PT OBTAINED A RESULT AROUND 8.0-9.0 MMOL/L AND TOOK HIS PRE-MEAL DOSE OF 6 UNITS "HUMALOG" INSULIN. BEFORE HE WAS ABLE TO EAT HIS MEAL, THE PT BEGAN TO HAVE IMPAIRED VISION AND FELT SLEEPY, HUNGRY, WEAK, SHAKY, SWEATY, AND DIZZY. AT THAT POINT, THE PT BECAME SUSPICIOUS OF THE REPORTED VIAL OF TEST STRIPS AND DECIDED TO TEST HIMSELF AGAIN USING A NEW VIAL OF TEST STRIPS. HE GOT RESULTS OF "3.8, 3.4, AND 3.8 MMOL/L." THE PT ADMINISTERED SELF-CARE BY CONSUMING A SPOON OF HONEY. THIS SELF-TREATMENT IMMEDIATELY RELIEVED HIS SYMPTOMS. THE PT FELT THE REPORTED VIAL OF TEST STRIPS GAVE HIM INACCURATELY HIGH RESULTS. THE PT TOOK HIS METER AND TEST STRIPS TO A PHARMACY. THE PHARMACY PERFORMED CONTROL SOLUTION TESTS ON ALL OF HIS 4 TEST STRIP BOTTLES INCLUDING THE REPORTED VIAL. ALL TEST STRIP VIALS PASSED THE CONTROL SOLUTION TESTS. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS USING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT OBTAINED RESULTS OF "9.2, 8.0, AND 8.9 MMOL/L" AROUND BREAKFAST TIME. THE PT TOOK 6 UNITS OF PRE-BREAKFAST INSULIN, DEVELOPED SYMPTOMS OF HYPOGLYCEMIA, RETESTED ON A NEW VIAL OF TEST STRIPS, AND GOT RESULTS OF "3.8, 3.4 AND 3.8 MMOL/L." THE SIX REPORTED TEST RESULTS WERE PERFORMED WITHIN A 20 MINUTE TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2567369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R