BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2223382 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08100
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/10/2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT YET BEEN RETURNED TO LIFESCAN FOR PRODUCT ANALYSIS EVALUATION. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS ONE TOUCH ULTRAMINI METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE ADVOCATE AND THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. AT AN UNSPECIFIED TIME EARLIER IN THE DAY OF (B)(6) 2011, THE PATIENT CLAIMED HE HAD TESTED WITH THE SUBJECT METER AND OBTAINED A RESULT OF "981 MG/DL" ON THE SUBJECT METER. PER THE METER'S OWNER MANUAL THE METER'S RESULTS REPORTED RANGE IS FROM "20-600 MG/DL". PER THE CCA, THE CUSTOMER CONFIRMED AND INSISTED 3 SEPARATE TIMES, IT WAS "981 MG/DL". HE ALSO STATED THAT DUE TO THAT HIGH READING, HE SELF TREATED WITH 100U OF INSULIN (UNKNOWN TYPE AND TIME ADMINISTERED). SUBSEQUENTLY AT AROUND 5 PM, HE FELT LIGHTHEADED, DIZZY AND WITH COLD SWEATS. REPORTEDLY THE PATIENT RECEIVED TREATMENT DUE TO HIS SYMPTOMS, BUT IT IS UNKNOWN WHAT KIND OF TREATMENT WAS ADMINISTERED OR WHEN AND WHO ADMINISTERED IT. AT 5:30 PM, HE OBTAINED RESULTS OF "190, 196, AND 220 MG/DL" ON THE SUBJECT METER, WHICH HE COMPARED TO HIS FEELINGS/NORMAL READINGS AND FELT THEY WERE INACCURATE HIGH. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER AND WAS USING CORRECT UNEXPIRED STRIPS. THE CCA WAS UNABLE TO VERIFY THE "981 MG/DL" READING IN THE METER'S MEMORY TO CONFIRM IF IT MAY HAVE BEEN ACCIDENTALLY READ UPSIDE DOWN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY 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. 3145087

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R