BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2251389 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09138
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    September 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (10/19/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 2011 THE METER WAS TESTED AND NO FAULTS WERE FOUND. ON (B)(6), 2011 THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN INACCURATE HIGH ISSUE WITH HER ONE TOUCH ULTRAMINI METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED DAY, APPROXIMATELY 4 MONTHS PRIOR TO CONTACTING LFS. SHE OBTAINED A RESULT OF "250 MG/DL" ON THE SUBJECT METER, A "47 MG/DL" ON A FREESTYLE METER AND "144 MG/DL" ON THE DOCTOR'S METER, DONE LESS THAN 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. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. SHE CLAIMED 2-3 WEEKS AFTER THE ALLEGED ISSUE STARTED, SHE FELT LIGHTHEADED AND SHAKY, WHICH SHE ASSOCIATED TO SYMPTOMS OF A HYPERGLYCEMIC STATE AND DECIDED TO TREAT IT BY EATING LESS FOOD AND DRINK. THE PATIENT REMEMBERS OBTAINING RESULTS BETWEEN "140-180 MG/DL" WHILE SHAKY AND LIGHTHEADED, WHICH CONFIRMED TO HER THAT HER BLOOD GLUCOSE WAS ELEVATED. SHE EXPLAINED TO THIS MSS, THAT THESE SYMPTOMS AND TREATMENT WENT ON FOR A FEW DAYS, AND THEN SHE DECIDED TO EAT MORE FOOD AND SUDDENLY HER SYMPTOMS DISAPPEARED. SHE REALIZED THEN THAT HER SYMPTOMS HAD BEEN OF A HYPOGLYCEMIC STATE AND HER METER WAS GIVING HER FALSE HIGH VALUES. THE PATIENT DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT DUE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND USING AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, WHILE FEELINGS SYMPTOMS SUGGESTIVE OF SEVERE 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. 3041408

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R