BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1695591 · Received May 17, 2010

    Report

    Report Number
    2939301-2010-03842
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    March 20, 2010
    Report Date
    May 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/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 THE FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READINGS OF "303, 252, 277, 276, AND 273 MG/DL" COMPARED TO ANOTHER METER. THE PT COULD NOT PROVIDE ANY NUMERIC READINGS FOR THE OTHER METER. ON (B) (6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL. THE PT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. DURING THE CALLBACK, THE PT STATED THAT SHE TOOK 14 UNITS OF HUMALOG INSULIN PER AN UNSPECIFIED LFS METER READINGS ON (B) (6) 2010. THE PT'S BLOOD GLUCOSE READING REPORTEDLY CORRELATED WITH THE WAY SHE WAS FEELING AT THE TIME OF CONCERN. THE PT COULD NOT RECALL THE NUMERIC VALUE OF HER BLOOD GLUCOSE READING. LATER THAT DAY AROUND THE EARLY AFTERNOON TIME, THE PT CLAIMED THAT SHE WENT INTO "INSULIN SHOCK" AND WAS FEELING "LOW BLOOD GLUCOSE SYMPTOMS." THE PT'S HUSBAND CALLED THE PARAMEDIC. UPON ARRIVAL THE PT OBTAINED A BLOOD GLUCOSE READING OF "27 MG/DL" ON THE EMS METER. NO GLUCOSE READING WAS TAKEN ON THE SUBJECT METER AT THE TIME OF CONCERN. THE PT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED WITH IV GLUCOSE FOR 3 HOURS IN THE ER. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE REPORTED READINGS WERE TAKEN MORE THAN 30 MINS OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE WENT INTO "INSULIN SHOCK" AND RECEIVED TREATMENT FOR HYPOGLYCEMIA AFTER SHE TOOK INSULIN PER THE LFS METER READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R