BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2183109 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06573
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT BEEN RETURNED TO LIFESCAN FOR PRODUCT ANALYSIS. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. ON (B)(6) 2011, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT'S DAUGHTER SINCE THE PATIENT WAS NOT AVAILABLE, AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT'S DAUGHTER COULD NOT RECALL AN EXACT DATE THAT THE ALLEGED ISSUE BEGAN BUT STATED SHE WAS HAVING PROBLEMS WITH THE SUBJECT METER SINCE "EARLY (B)(6)." SHE INFORMED THE MSS THAT THE PATIENT MANAGES HER DIABETES WITH GLUCOPHAGE AND JANUVIA PILLS AND CHECKS HER BLOOD GLUCOSE ONCE PER DAY, BEFORE BREAKFAST. THE DAUGHTER STATED HER MOTHER PERFORMED HER MORNING TEST IN (B)(6) (UNKNOWN DATE) AND RECEIVED A "169 MG/DL" WHICH SHE FELT WAS HIGHER THAN IT SHOULD HAVE BEEN. PER THE DAUGHTER, HER MOTHER SAID HER BLOOD SUGAR IS "LOWER" IN THE MORNINGS BUT SHE COULD NOT GIVE SPECIFICS. THE PATIENT REPORTEDLY RETESTED AND RECEIVED THE FOLLOWING READINGS, "183, 189, 130 MG/DL" HOWEVER THE TIME DIFFERENCE BETWEEN THE TESTS WAS GREATER THAN 20 MINUTES. THE PATIENT REPORTEDLY TOOK AN EXTRA PILL OF JANUVIA IN RESPONSE TO THE METER RESULTS. THE DAUGHTER ALLEGED THAT THE PATIENT EXPERIENCED SYMPTOMS OF "FEELING HOT AND SWEATING" 1-2 HOURS AFTER TESTING AND HAVING BREAKFAST AND REPORTEDLY TREATED HER SYMPTOMS WITH SOME ORANGE JUICE. THE DAUGHTER CLAIMED THAT THE PATIENT HAS SINCE EXPERIENCED THESE SYMPTOMS INTERMITTENTLY FOR APPROXIMATELY "ONE MONTH" AND REPORTED THAT WHEN THIS OCCURS, SHE WOULD TREAT HERSELF WITH ORANGE JUICE ALONG WITH SOMETHING TO EAT AND WOULD FEEL BETTER 20-30 MINUTES AFTER TREATMENT. THE PATIENT CONTINUED TO TEST ON THE SUBJECT METER AS NORMAL AND REPORTEDLY TOOK HER DIABETES PILLS AS USUAL. THE DAUGHTER CLAIMED THAT WITHIN THE LAST MONTH THE PATIENT ALSO RECEIVED A READING OF "401 MG/DL" BUT WOULD FEEL "HOT AND SWEATY" WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. SHE DENIED THAT THE PATIENT HAS MADE ANY CHANGES TO HER DIET OR ACTIVITY LEVEL. THE DAUGHTER STATED THAT THE PATIENT HAD A ROUTINE DOCTOR'S APPOINTMENT APPROXIMATELY 2 WEEKS AGO AND HER DOCTOR DREW BLOOD FROM HER ARM FOR A LAB TEST WHICH PER THE DAUGHTER CAME BACK AS "NORMAL." AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE WAS ABLE TO CONFIRM THAT THE BLOOD SAMPLE WAS TAKEN FROM THE SAME APPROVED SOURCE. THE CORRECT TEST STRIPS WERE UNEXPIRED. IT WAS NOT KNOWN IF THE PATIENT PERFORMED A CONTROL SOLUTION TEST REGULARLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S DAUGHTER CLAIMS THE PATIENT OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, INCREASED HER DOSE OF MEDICATION FOR DIABETES AND ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3079618

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R