BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONT TOUCH ULTRA METER

    MDR report key: 1620632 · Received March 1, 2010

    Report

    Report Number
    2939301-2010-01191
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 ULTRA METER IS GIVING THE SAME READING OF 157 MG/DL OVER AN EIGHT HOUR PERIOD. ON FEBRUARY 26, 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL. THE PT TESTS HER BLOOD GLUCOSE 4 TO 5 TIMES PER DAY AND MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. ON (B) (6) 2010 AT AROUND NOONTIME, THE PT TESTED HER BLOOD GLUCOSE AT "157 MG/DL" ON THE SUBJECT METER AND TOOK 18 UNITS OF APIDRA BASED ON HER SLIDING SALE. THE PT ATE HER LUNCH AS USUAL. AT AROUND 6 PM, THE PT OBTAINED A BLOOD GLUCOSE READING OF "157 MG/DL" AGAIN AND TOOK 20 UNITS OF APIDRA BEFORE DINNERTIME. THE PT ATE HER DINNER AT THE TIME OF CONCERN. APPROX 30 MINUTES LATER, THE PT DEVELOPED SYMPTOMS DESCRIBED AS "SWEATS, SHAKES, AND BLURRED VISION." THE PT TESTED AT "157 MG/DL" ON THE SUBJECT METER AGAIN, WHICH THE PT FELT WAS INACCURATELY HIGH COMPARED TO HER SYMPTOMS AT THE TIME OF CONCERN. THE PT DRANK ORANGE JUICE AND FELT BETTER SOON AFTER. LATER THAT NIGHT, SHE TESTED AT "316 MG/DL" ON THE SUBJECT METER. THE PT DID NOT REQUIRE ANY OTHER TREATMENT AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. IN ADDITION, THE CCA NOTED THAT THE PRODUCT ISSUE WAS DUE TO A USER ERROR. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN PER THE ALLEGED "157 MG/DL" OBTAINED ON THE LFS METER. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONT TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2947308

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R