BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1961853 · Received January 14, 2011

    Report

    Report Number
    2939301-2011-00511
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    January 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 01/28/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. ON (B)(6) 2011, THE PATIENT SPOKE WITH THE DIRECTOR OF POST MARKET RISK MANAGEMENT AND SURVEILLANCE AND REFUSED TO SPEAK WITH A MEDICAL SURVEILLANCE SPECIALIST (MSS). THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ANY ADDITIONAL INFORMATION OFFERED BY THE PATIENT PER HER CONVERSATION WITH THE HEAD OF MEDICAL SURVEILLANCE. THE ALLEGED ISSUE BEGAN IN (B)(6) (YEAR NOT CONFIRMED). AT AN UNSPECIFIED TIME AFTER, THE PATIENT STATED SHE PURCHASED ANOTHER DEVICE. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "310 AND 280 MG/DL" WITH THE SUBJECT METER AND "216 MG/DL" ON ANOTHER 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 CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). PRIOR TO COMPARING METER RESULTS, THE PATIENT STATED SHE HAS BEEN ADJUSTING HER INSULIN BASED ON THE ALLEGED INACCURATE RESULTS OBTAINED FROM THE SUBJECT METER. AS A RESULT OF ACTION TAKEN, THE PATIENT CLAIMED SHE FELT LOW BLOOD GLUCOSE SYMPTOMS INCLUDING SHAKINESS AND FEELING COLD. THE PATIENT STATED SHE TOOK "GLUCOSE" AS TREATMENT (TYPE NOT CLEAR). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST WHICH FELL WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3066149

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R