BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1780060 · Received August 2, 2010

    Report

    Report Number
    2939301-2010-06171
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Report Date
    July 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. 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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT'S WIFE CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING THAT THE ONETOUCH ULTRAEASY METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. ON THE MORNING OF (B)(6), 2010 (AT 7AM), THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "5.4 MMOL/L" WITH THE SUBJECT METER. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED INACCURATE HIGH READING. AT AN UNKNOWN TIME LATER, THE REPORTER CLAIMED THE PATIENT WAS SWEATING, HIS FACE HAD DROPPED TO ONE SIDE, AND HE WAS UNABLE TO COMMUNICATE. THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND ARRIVED AT APPROXIMATELY 7:45AM. PER CSR DOCUMENTATION THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "3 MMOL/L" WITH THE EMS'S METER AND WAS SOON AFTER ADMINISTERED (BY EMS) A GLUCOSE TABLET ALONG WITH FOOD. AT AN UNKNOWN TIME LATER THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "6.8 MMOL/L" WITH THE EMS'S METER AND THE PATIENT'S SECONDARY (ONETOUCH ULTRAEASY) METER. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MMOL/L) AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 1 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2924416

    Patients

    Seq Age Sex Outcome Treatment
    1