BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2122531 · Received June 13, 2011

    Report

    Report Number
    2939301-2011-04794
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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. 510K # K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING OF "160 MG/DL" COMPARED TO ANOTHER METER READING OF "90 MG/DL." THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE INITIAL DOCUMENTATION AND THE FOLLOW-UP INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE TWICE PER DAY AND MANAGES HIS DIABETES WITH INSULIN. HE TAKES 44 UNITS OF INSULIN: 40 UNITS OF NPH AND 4 UNITS OF REGULAR INSULIN, IN THE MORNING AND THE SAME AMOUNT (40 UNITS OF NPH AND 4 UNITS OF REGULAR INSULIN) AT NIGHT. WHEN HIS BLOOD GLUCOSE IS LOWER THAN 100 MG/DL FIRST HE EATS SOME FOOD AND THEN HE APPLIES INSULIN; HOWEVER, IF HIS BLOOD GLUCOSE IS HIGHER THAN 100 MG/DL, HE ALWAYS TAKES HIS USUAL DOSES OF INSULIN: 44 UNITS. REPORTEDLY, HE TESTED AT "160 MG/DL" ON THE SUBJECT AND TOOK HIS USUAL INSULIN ON (B)(6) 2011 AT 6 AM. APPROXIMATELY 30 MINUTES LATER, THE PATIENT FELT COLD SWEAT AND LOST CONSCIOUSNESS. HIS WIFE GAVE HIM SUGAR AND TOOK HIM TO THE EMERGENCY ROOM WHERE HE RECEIVED FURTHER TREATMENT WITH IV GLUCOSE AT 7AM. HIS BLOOD GLUCOSE READING WAS TESTED AT "38 MG/DL." HE LEFT THE HOSPITAL AT ABOUT 8:00 AM. AT 10:30 AM, THE PATIENT HAD SYMPTOM OF COLD SWEAT START AGAIN AND HIS WIFE GAVE HIM FOOD (3 BANANAS). HIS SYMPTOMS ABATED SOON AFTER. AT THAT TIME HIS BLOOD GLUCOSE WAS 90MG/DL. THE REPORTER FELT HAD THE LFS METER GAVE THE CORRECT READING ON THE DAY OF THE EVENT, THE PATIENT WOULD HAVE ATE BEFORE HE TOOK HER USUAL INSULIN AND PREVENTED THE ALLEGED HYPOGLYCEMIC EPISODE. DURING TROUBLESHOOTING, THE PATIENT NOTED THE REPORTED METER READINGS OF "160 MG/DL" AND "90 MG/DL" WERE TAKEN WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED TREATMENT FOR HYPOGLYCEMIA AFTER HE TOOK INSULIN PER THE LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R