BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 734277 · Received July 7, 2006

    Report

    Report Number
    2939301-2006-00943
    Event Type
    Injury
    Date Received
    July 7, 2006
    Report Date
    June 28, 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 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

    IN 2006 THE LAY USER/REPORTER (PT'S WIFE) CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRA WAS READING INACCURATELY HIGH COMPARED TO HIS SYMPTOMS AND THE CONTROL SOLUTION TESTS WERE FAILING. THE M EDICAL SPECIALIST SPOKE DIRECTLY WHT THE PT 2 DAYS LATER TO OBTAIN/VERIFTY THE FOLLOWING INFO. THE PT STATES THAT HIS BLOOD GLUCOSE USUALLY STAYS AROUND "110-120 MG/DL AND USUALLY TAKES ABOUT 10-15 UNITS OF HUMALOG. THE PT STATED THAT SHE DOES NOT HAVE A SPECIFIC SLIDING SCALE AND DECIDES ON HIS OWN HOW MUCH HUMALOG TO TAKE. THE PT WAS ALSO RECENTLY PRESCRIBED A FAST-ACTING INSULIN (NOVOLOG FLEX PEN) IN 2005, BUT HAD NOT USED IT YET. IN 2006 AT 5AM, THE PT GOT A METER READING OF "220 MGL/DL" WITH NO SYMPTOMS AND DECIDED ON HIS OWN TO TAKE 25 UNITS OF HUMALOG BASED ON THE METER READING. AT 8:30AM, THE PT RETESTED AFTER TAKING A WALK, GOT A "200 MG/DL, AND THEN ATE A "LIGHT" LUNCH. AT 3PM AND 4PM, THE PT RETESTED AND GOT "230 MG/DL." CONCERNED THAT HIS BLOOD GLUCOSE LEVELS WERE STILL "HIGHT," THE PT TOOK 25 UNITS OF HUMALOG AT 4:15PM AND CALLED HIS WIFE, NOT THE DR AS PREVIOUSLY NOTED BY THE CCA, FOR ADVICE ON IF HE SHOULD TAKE THE FAST ACTING INSULIN, BUT ENDED UP NOT TAKING ANY . AT 5:40PM, THE PT GOT A '154 MG/DL" ON HIS METER WHILE FEELING "LOW" WITH SYMPTOMS OF COLD IN CHEST, FATIGUE, TREMORS, AND THIRSTY, THE PT FELT THAT THE METER READING WAS HIGH COMPARED TO HIS SYMTPOMS SO HE RETESTED ON HIS NEIGHBOR'S METER AND GOT A "54 MG/DL," WHICH WAS PERFORMED WITHIN 10 MINUTES FROM HIS METER READING. FOLLOWING THE BLOOD GLUCOSE TESTS, THE PT ATE TWO PIECES OF CANDY AND A SLICE OF CAKE; HE FELT BETTER WITHIN 30 MINUTES. THE PT RAN THREE CONTROL SOLUTIONS TESTS THAT ALL FAILED. THE RESULTS WERE "182, 167 AND 182 MG/DL" WITH A CONTROL SOLTUION RANGE OF "95-129 MG/DL". "THE CUSTOMER CARE ADOVATE VERIFIED THAT THE METER WAS SET UP CORRECTLY; HOWEVER, THE CONTROL SOLTUION WAS PAST THE DISCARD DATE, WHICH CAN CONTRIBUTE TO INACCURATE CONTROL READINGS ON THE METER. THE MAS VERIFIED THAT THE TEST STRIPS WERE IN GOOD CONDITION AND WERE NOT PAST THE DISCARD/EXPIRATION DATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT WAS EXPERIENCING NONSPECIFIC SYMPTOMS THAT COULD SUGGEST HYPOGLYCEMIA, WHICH DOES NOT CORRELATE WITH THE PT'S REPORTED METER READING OF "154 MG/DL." IN ADDITION, THE CALCULATED DIFFERENCE OF THE "154 AND 54 MG/DL" METER READINGS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY BETWEEN TWO METERS. 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 2538709

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R