BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2172520 · Received July 22, 2011

    Report

    Report Number
    2939301-2011-06094
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K073231. LIFESCAN RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATIONS ON (B)(6) 2011. THE RETURNED METER WAS FOUND TO HAVE DRIED BLOOD ON THE PIN 1 AND PIN 2 OF THE TEST STRIP PORT CONNECTOR. IN ADDITION, AND UNREPORTED ISSUE WAS FOUND DURING TESTING (THE SPC PIN 2 WAS FOUND TO BE HIGH). METER FOUND TO HAVE PIN1, PIN 2 OF STRIP PORT CONNECTOR DIRTY WITH DRIED BLOOD.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN ISSUE WITH HER ONE TOUCH ULTRALINK METER CONTINUING TO PROMPT THE MESSAGE OF "APPLY SAMPLE" EVEN AFTER A BLOOD SAMPLE HAD BEEN APPLIED TO THE TEST STRIP AS WELL AS THE "ER4" AND "ER5" PROMPTS AS WELL. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUES WITH THE SUBJECT METER STARTED ON (B)(6) 2011 AT 1 PM. ACCORDING TO THE CALL DOCUMENTATION, THE PATIENT WAS UTILIZING 2 DIFFERENT LOT NUMBERS OF STRIPS AND WAS EXPERIENCING ALL 3 DIFFERENT PROMPTS ON THE SAME METER. SHE STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (PUMP THERAPY), AND DUE TO THE ALLEGED ISSUES WITH SUBJECT METER, SHE DID NOT TAKE ANY ACTION IN REGARDS TO HER USUAL ROUTINE. THE PATIENT CLAIMED THAT AN HOUR LATER, AFTER THE PRODUCT ISSUES BEGAN, SHE HAD DRY MOUTH AND DID NOT FEEL WELL. IN RESPONSE TO HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE AND CORRECT UNEXPIRED STRIPS. THE MULTIPLE ISSUES WERE RESOLVED DURING THE INITIAL CALL WITH CUSTOMER SERVICE. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA AND DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. DURING THE CUSTOMER SERVICE INVESTIGATION, THERE WAS NO EVIDENCE THAT THE PRODUCT MALFUNCTIONED. ON (B)(6) 2011, LFS COMPLETED DEVICE EVALUATIONS ON THE RETURNED METER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FAILED PRODUCT ANALYSIS TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3009148

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR