BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2882930 · Received December 21, 2012

    Report

    Report Number
    3008382007-2012-08788
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (2/22/2013)-DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE FOUND HAVE RESULTS OUTSIDE OF THE CONTROL SOLUTION RANGE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN (B)(6) 2012. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "AROUND 300 MG/DL" WITH THE SUBJECT METER. IT IS NOT CLEAR HOW THE PATIENT MANAGES HIS DIABETES; HOWEVER, THAT MORNING, THE PATIENT ADMINISTERED SELF 17 UNITS HUMULIN INSULIN. AN HOUR AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS HE FELT SYMPTOMS OF CLAMMY AND WEAKNESS. TREATMENT WAS NOT SPECIFIED. ON THE MORNING OF (B)(6) 2012, THE PATIENT REPORTEDLY VISITED HIS PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "AROUND 125 MG/DL" WITH THE PHYSICIAN'S METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3373538

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening