BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2193421 · Received August 5, 2011

    Report

    Report Number
    2939301-2011-06919
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 K073231.

    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 HER ONE TOUCH ULTRALINK 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 (B)(6) 2011, AT 5:11 PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "93 MG/DL" WITH THE SUBJECT METER AND "37 MG/DL" ON A ONE TOUCH ULTRA2 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 FELT THE SUBJECT METER WAS READING INACCURATELY HIGHER THAN ULTRA2 METER AND ALSO WHEN COMPARED TO HIS FEELINGS. HE COULD NOT RECALL THE PREVIOUS RESULTS HE OBTAINED FROM THE SUBJECT METER, BUT FEELS THEY MUST HAVE BEEN ACCURATE. THE PATIENT REPORTED THAT HE CHECKS HIS GLUCOSE 4X/DAY AND MANAGES HIS DIABETES WITH THE INSULIN PUMP, AND DUE TO THE ALLEGED PRODUCT ISSUE, DENIED MAKING ANY CHANGES TO HIS REGULAR TREATMENT. THE PATIENT CLAIMED THAT A FEW MINUTES BEFORE THE COMPARISON WAS MADE, AT 5:07 PM, HE REPORTEDLY FELT WEAK WHICH HE ASSOCIATED TO A LOW GLUCOSE AND IT PROMPTED HIM TO TEST EXPECTING A LOW RESULT. AFTER GETTING AN ACCURATE LOW RESULT WITH THE OTHER METER, AND IN RESPONSE TO HIS SYMPTOM, HE IMMEDIATELY TREATED HIMSELF WITH ORANGE JUICE AND REPORTEDLY FELT BETTER WITHIN 15 MINUTES. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE AND THE METER WAS SET TO CORRECT UNIT OF MEASURE. DURING TROUBLESHOOTING, THE CONTROL SOLUTION TEST WAS NOT PERFORMED ON THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S SYMPTOMS DO NOT MEET LFS'S CRITERIA FOR A SERIOUS INJURY AND THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3065487

    Patients

    Seq Age Sex Outcome Treatment
    1