BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2474018 · Received March 1, 2012

    Report

    Report Number
    2939301-2012-02099
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    February 18, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE 510(K) # IS K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4) 2012 THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE METER'S CASING WAS FOUND TO HAVE PAINT DAMAGE. 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) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRALINK METER READ INACCURATELY ERRATIC WHEN COMPARING RESULTS TAKEN ONE AFTER ANOTHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN THE SECOND WEEK OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP AND ORAL MEDICATIONS (TYPES NOT SPECIFIED). IT IS NOT KNOWN IF CHANGES WERE MADE TO THE PATIENT'S DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED ISSUE. THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ''132, 164, 224 AND 191 MG/DL'' WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS. NO ADDITIONAL TREATMENT WAS SPECIFIED. AT AN UNSPECIFIED DATE/TIME, THE REPORTER STATED THE PATIENT TESTED HER BLOOD GLUCOSE ON ANOTHER DEVICE. RESULTS OBTAINED WITH THE OTHER DEVICE WERE NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS DUE TO THE ALLEGED ISSUE. ADDITIONALLY, THERE IS NO INDICATION THE PATIENT RECEIVED MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3227229

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR