BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1850632 · Received October 1, 2010

    Report

    Report Number
    2939301-2010-08697
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 K073231.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "281 AND 279 MG/DL" WITH THE SUBJECT METER AND "252, 197, AND 241 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF SOME OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT ADVISED THE CCA HE MANAGES HIS DIABETES WITH INSULIN. AT AN UNSPECIFIED TIME AND/ OR DATE, THE PATIENT CLAIMED TOOK HIS HUMALOG INSULIN (AMOUNT NOT CLEAR). ABOUT 2 WEEKS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT STATED HE FELT SYMPTOMS OF NAUSEA AND LIGHT HEADED. ON (B)(6), 2010 AT 518AM, THE PATIENT ADVISED HE INCREASED HIS DOSE OF AN UNSPECIFIED MEDICATION TO 100 MG. 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. 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 SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS¿S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL WAS PLACED IN THE RIGHT FEMORAL ARTERY WITH GOOD HEMOSTASIS POSTPROCEDURE. THERE WAS NO TRAUMA TO THE VEIN DURING ACCESS TO THE RIGHT FEMORAL ARTERY. THE VEIN WAS CLEARLY STUCK TWICE BUT THERE WAS IMMEDIATE REMOVAL OF THE NEEDLE AND NO TRAUMA OR HEMATOMA. THE PATIENT WAS ADMITTED THE FOLLOWING DAY WITH A DEEP VEIN THROMBOSIS (DVT) OF THE RIGHT COMMON FEMORAL VEIN. CLEARLY CANNOT COMPLETELY EXCLUDE THIS AS A CONTRIBUTING FACTOR FOR THE DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3036943

    Patients

    Seq Age Sex Outcome Treatment
    1