BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2122476 · Received June 13, 2011

    Report

    Report Number
    2939301-2011-04792
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 510K #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 WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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/REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE LOW READINGS COMPARED TO NORMAL READING/FEELING. THIS COMPLAINT IS CLASSIFIED BASED ON THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE AND THE FOLLOW-UP INFORMATION. THE PATIENT TESTS FOUR TIMES A DAY AT A MINIMUM BEFORE EACH MEAL AND TWO HOURS AFTER EACH MEAL. SOMETIMES SHE WILL TEST BEFORE BED AS NEEDED. SHE DOES NOT TAKE ANY DIABETES MEDICATION TO MANAGE HER CONDITION. ACCORDING TO THE PATIENT, SHE REPORTEDLY HAD HIGH SYMPTOMS DESCRIBED AS "THIRSTY, DIZZY, HEADACHE, AND VISION PROBLEMS" PRIOR TO THE ALLEGED INACCURATE LOW READINGS. SHE COULD NOT PROVIDE ANY READINGS ON THE DAY OF CONCERN PRIOR TO THE ALLEGED SYMPTOMS BUT INDICATED THAT THE READINGS WERE ALL OVER THE PLACE. DESPITE THE LOW READINGS, THE PATIENT ADMINISTERED SELF TREATMENT FOR HYPERGLYCEMIA. HER REPORTED SYMPTOMS ABATED ONE HOUR AFTER SHE BEGAN DRINKING MORE WATER. THE PATIENT FELT THAT IF THE LFS METER WAS READING CORRECTLY, SHE COULD HAVE PREVENTED THE ALLEGED HYPERGLYCEMIC EPISODE BY CONTROLLING HER DIET. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE EXPERIENCED HYPERGLYCEMIA DUE TO THE ALLEGED INACCURATE LOW ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3127607

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R