BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PROFILE METER

    MDR report key: 1998292 · Received February 22, 2011

    Report

    Report Number
    2939301-2011-01550
    Event Type
    Injury
    Date Received
    February 22, 2011
    Report Date
    February 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) HAVE NOT BEEN RETURNED TO LIFESCAN FOR EVALUATION. NO INVESTIGATION WILL BE COMPLETED AT THIS TIME SINCE THE REPORTED TEST STRIP HAVE EXCEEDED THE SHELF LIFE. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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 K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH PROFILE METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER . THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY IN (B)(6) 1998 PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "238 AND 168 MG/DL" WITH THE SUBJECT METER AND "62 MG/DL" ON ANOTHER METER(BAYER BRAND METER), PERFORMED WITHIN 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 CLAIMED HE MANAGES HIS DIABETES WITH INSULIN. AFTER OBTAINING THE READING OF "238 MG/DL" ON THE SUBJECT METER, THE PATIENT CLAIMED HE ADMINISTERED 7-8 UNITS OF REGULAR INSULIN AS USUAL IN (B)(6) 1998. AT AN UNKNOWN DATE/TIME, THE PATIENT CLAIMED HE FELT "CRUMMY"; HOWEVER HE WAS NOT ABLE TO SPECIFY WHETHER THE SYMPTOM OCCURRED BEFORE OR AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED AFTER HE OBTAINED HIS READINGS ON BOTH METERS AND ADMINISTERED INSULIN, HE LEFT HIS MOTHER'S HOUSE AND LATER WAS INVOLVED IN AN ACCIDENT THAT WRECKED HIS CAR. DUE TO THE ACCIDENT, THE PATIENT INDICATED HE WAS ASSISTED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT CLAIMED EMS TESTED HIS BLOOD GLUCOSE AT "42 MG/DL" WITH THEIR METER AND THEN HE WAS ADMINISTERED IV GLUCOSE. PER THE CCA DOCUMENTATION, AFTER HIS TREATMENT FROM EMS THE PATIENT MENTIONED REFUSED TO RECEIVE ANY ADDITIONAL TREATMENT FROM THE ACCIDENT, SO HE WAS RELEASED TO GO HOME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS FROM THE SUBJECT METER AND THE METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING; HOWEVER THE PATIENT WAS NOT ABLE TO PERFORM A QUALITY CONTROL TEST WITH THE CONTROL SOLUTION AND CHECK STRIP TEST SINCE HE NO LONGER HAD THE METER AND PRODUCTS AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, IT IS NOTED THAT THE PATIENT REPORTED AN ALLEGED ISSUE THAT HAPPENED IN 1998; HOWEVER IT IS NOT KNOWN AS TO WHY THE PATIENT REPORTED THE ALLEGED ISSUE NOW. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY RECEIVED HCP INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention