BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2813464 · Received October 31, 2012

    Report

    Report Number
    2939301-2012-12553
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 8, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND; THE METER FUNCTIONED PROPERLY. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING IN ACCURATELY LOW COMPARED TO ANOTHER DEVICE (ONETOUCH ULTRASMART). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOWN WHEN THE ALLEGED ISSUE FIRST BEGAN. ON AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF 22, 35MG/DL, AND LO WITH THE SUBJECT METER AND 207MG/DL WITH THE ONETOUCH ULTRASMART METER. IT IS NOT KNOWN HOW MUCH TIME ELAPSED BETWEEN THE REPORTED READINGS, HOWEVER, IF THE RESULTS WERE TAKEN WITHIN 30 MINUTES FROM EACH OTHER BASED ON STATISTICAL MYTHOLOGY, THE CALCULATED DIFFERENCES OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30 MG/DL. THE PATIENT REPORTEDLY DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN, AND IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. IT IS NOT CLEAR IF THE PATIENT HAD DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE NOR IS IT CLEAR IF THE PATIENT RECEIVED ANY FORM OF TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT; HOWEVER, THE CSR WAS UNABLE VERIFY IF THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE AND IF THE PATIENT OBTAINED THE BLOOD SAMPLE FROM AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(6) 2012 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND AND WAS FOUND TO ALSO FUNCTION PROPERLY. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT SUFFER FROM ANY SERIOUS INJURIES AND DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3352186

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR