BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2221637 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07980
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    August 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) # IS K073231. ON 7/25/2011, LFS RECEIVED THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT. DEVICE EVALUATION WAS COMPLETED WITH THE RETURNED METER ON 07/27/2011 AND NO FAULTS WERE FOUND WITH THE PRODUCT. DEVICE EVALUATION WAS COMPLETED WITH THE RETURNED TEST STRIPS ON (B)(4) 2011 AND FOUND THAT THE CONTROL SOLUTION TEST WAS ABOVE THE EXPECTED RANGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH WITH BOTH BLOOD AND CONTROL SOLUTION SAMPLES. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IMMEDIATELY BEFORE THE PATIENT CONTACTED LFS FOR ASSISTANCE. THE PATIENT ALLEGEDLY PERFORMED A BLOOD TEST ON THE SUBJECT METER AND RECEIVED A READING OF "300 MG/DL" WHICH SHE FELT WAS HIGH COMPARED TO HER USUAL READINGS AND FEELINGS. THE PATIENT ALSO REPORTED AT THE SAME TIME, SHE PERFORMED A CONTROL SOLUTION TEST ON THE SUBJECT METER AND RECEIVED A READING OF "187 MG/DL" WHICH FELL HIGH OUTSIDE THE RANGE PRINTED ON THE VIAL OF THE SUBJECT TEST STRIPS (107-142 MG/DL). PER THE CCA'S NOTES, THE PATIENT MANAGES HER DIABETES USING AN INSULIN PUMP (UNKNOWN TYPE AND DOSE). THE PATIENT REPORTEDLY INCREASED HER DOSE OF INSULIN IN RESPONSE TO THE HIGH READINGS AND STATED SHE FELT "NERVOUS" AFTER TESTING. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT AND CALLED LFS TO REPORT THE PROBLEM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CONTROL SOLUTION MAY HAVE BEEN OPENED LONGER THAN ITS DISCARD DATE AND DIDN'T HAVE ANY NEW CONTROL SOLUTION TO TEST THE SUBJECT METER AND TEST STRIPS WITH. IT WAS NOT KNOWN WHEN THE PATIENT'S TESTING TECHNIQUE WAS ACCORDING TO LABELING INSTRUCTIONS EITHER, BUT THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON INFORMATION THAT WAS OBTAINED FROM THE CUSTOMER SERVICE CALL, THIS COMPLAINT IS BEING RULED OUT AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. IN ADDITION, THERE WAS NO EVIDENCE THAT THE PRODUCT MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3125615

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR