BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1982657 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01244
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2011 ALLEGING THAT THE ONETOUCH ULTRA METER READING INACCURATELY HIGH COMPARED TO THE LAB RESULT. THE PATIENT'S DIABETES IS MANAGED WITH INSULIN- NO ADJUSTABLE SLIDING SCALE. THE PATIENT ALLEGEDLY ENCOUNTERED THE INACCURATELY HIGH READINGS ON TWO OCCASIONS. ON (B)(6) 2011, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "171 MG/DL" ON THE SUBJECT METER AND "136 MG/DL" ON THE LAB INSTRUMENT. BASED ON THE READINGS FROM THE SUBJECT METER, THE PATIENT TOOK HER INSULIN REGIMEN, WHICH CONSISTED OF "22 UNITS BEFORE BREAKFAST AND 18 UNITS BEFORE DINNER" OF HUMINSULIN 30/70. SUBSEQUENTLY, THE PATIENT CLAIMED SHE WENT HYPOGLYCEMIC AND OBTAINED A BLOOD GLUCOSE READING OF "47 MG/DL" IN THE MORNING TIME (UNSPECIFIED DATE). ON (B)(6) 2011, THE PATIENT ONCE AGAIN COMPARED HER BLOOD GLUCOSE READING OF "110 MG/DL(FASTING) AND 307 MG/DL" ON THE SUBJECT METER COMPARED TO "78 (FASTING) AND 235 MG/DL" RESPECTIVELY ON THE LAB. THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF "22 UNITS BEFORE BREAKFAST AND 18 UNITS BEFORE DINNER" OF HUMINSULIN 30/70 AND CONSEQUENTLY DEVELOPED HYPOGLYCEMIC SYMPTOMS OF "VOMITING, SWEATING, AND SHIVERING." SINCE THE LAST HYPOGLYCEMIC EPISODE, THE PATIENT HAS CONSULTED WITH HER PHYSICIAN. HER FIXED INSULIN REGIMEN WAS ALTERED TO 6 UNITS BEFORE BREAKFAST AND 4 UNITS BEFORE DINNER. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE CALCULATED DIFFERENCE OF THE REPORTED METER TO LAB COMPARISON EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. HOWEVER, OUR CUSTOMER SERVICE NOTED THAT THE SAMPLE SITE USED TO OBTAIN A BLOOD GLUCOSE READING ON THE LFS METER WAS NOT APPROVED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT THE PATIENT CONTINUED TO TAKE HER INSULIN REGIMEN, WHICH WAS BASED ON THE ALLEGED INACCURATE HIGH LFS RESULTS, AND SUBSEQUENTLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3061933

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R