BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1822853 · Received September 1, 2010

    Report

    Report Number
    2939301-2010-07485
    Event Type
    Injury
    Date Received
    September 1, 2010
    Report Date
    August 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 BATTERY CONTACT CORRODED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER BROKE AT 38,905 JOULES. NO PT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER DOES NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS TWICE A DAY AND MANAGES HER DIABETES WITH NOVOLIN INSULIN (VIA INSULIN PUMP) BASED ON HER FOOD INTAKE AND HER BLOOD GLUCOSE RESULT ON THE SUBJECT METER. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 AT 9AM. THE PATIENT CLARIFIED THAT FROM (B)(6) 2010 SHE CONTINUED TO ADMINISTER HER INSULIN; HOWEVER, THE PATIENT STATED SHE WOULD BASE THE AMOUNT OF INSULIN ON HER CARBOHYDRATE CONSUMPTION. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE OCCURRED. THE PATIENT CONFIRMED SHE ADMINISTERED INSULIN (DOSAGE UNKNOWN) AT 10:30PM ON (B)(6) 2010, AND CLARIFIED IT WAS BEFORE CONSUMING HER FOOD. THE FOLLOWING MORNING, THE PATIENT STATED HER DAUGHTER FOUND HER UNCONSCIOUS AND THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. AT APPROXIMATELY 9AM ON (B)(6) 2010, THE PATIENT STATED SHE OBTAINED A BLOOD GLUCOSE RESULT OF "22 MG/DL" WITH THE EMS'S METER AND WAS SOON AFTER TRANSPORTED TO THE EMERGENCY ROOM (ER). DURING HER TIME IN THE ER, THE PATIENT STATED SHE WAS ADMINISTERED TREATMENT BY A HEALTH CARE PROFESSIONAL; HOWEVER TREATMENT IS UNKNOWN. THE PATIENT INDICATED SHE WAS NOT HOSPITALIZED; THE PATIENT STATED SHE WAS RELEASED A FEW HOURS LATER AFTER RECEIVING TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER DID NOT TURN ON WITH THE POWER BUTTON AND /OR TEST STRIP. THE CSR NOTED THAT THE BATTERIES IN THE SUBJECT METER DID NOT NEED TO BE REPLACED, PER OWNER'S MANUAL RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2841745

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening