BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2944891 · Received February 6, 2013

    Report

    Report Number
    3008382007-2013-02330
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY.LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED ON (B)(6) 2013 HE OBTAINED A READING OF "126MG/DL" ON THE LFS METER. THE PATIENT REPORTED UPON WAKING UP HE FELT "PRESSURE IN BETWEEN THE EYES." THE PATIENT REPORTED HE NORMALLY TESTS 8-10 TIMES A DAY AND HIS TARGET READINGS ARE BETWEEN "80 - 120MG/DL". THE PATIENT REPORTED USING HUMALOG INSULIN PUMP THERAPY TO MANAGE HIS DIABETES, AND BOLUSES DEPENDING ON BLOOD GLUCOSE READINGS. THE PATIENT REPORTED WITHIN 2 HOURS OF THE INITIAL READING, HE OBTAINED A READING OF "290MG/DL" WHICH HE BELIEVED TO BE ACCURATE AND GAVE HIMSELF A BOLUS OF HUMALOG INSULIN. THE PATIENT REPORTED WITHIN 45 MINUTES OF THE LAST READING, HE STARTED VOMITING PROFUSELY, WHICH IS VERY UNUSUAL FOR HIM. THE PATIENT REPORTED DRIVING HIMSELF TO THE URGENT CARE CLINIC WHICH TOOK 30 MINUTES. THE PATIENT REPORTED HE WAS SEEN BY A DOCTOR WHO BELIEVED IT WAS DIABETIC KETOACIDOSIS (DKA). THE PATIENT REPORTED THE URGENT CARE CLINIC DID NOT OBTAIN ANY BLOOD GLUCOSE READINGS, ADMINISTER ANY INSULIN OR IV FLUIDS. THE PATIENT REPORTED HIS WIFE THEN CAME AND PICKED HIM UP AND TRANSPORTED HIM TO THE HOSPITAL. THE PATIENT REPORTED UPON ARRIVAL, HE OBTAINED A READING OF "345MG/DL" ON THE LFS METER. THE PATIENT REPORTED HE HAD "CONSTANT VOMITING THE WHOLE TIME." THE PATIENT REPORTED HIS FEET ARMS AND LEGS WERE "FREEZING" AND HIS STOMACH WAS IN PAIN. THE PATIENT REPORTED HE WAS IN THE EMERGENCY ROOM (ER) FOR 7 HOURS, HE WAS GIVEN IV FLUIDS WITH AN INSULIN DRIP, A CHEST X-RAY, CAT SCAN OF HIS STOMACH. THE PATIENT REPORTED, HE FINALLY WENT TO THE INTENSIVE CARE UNIT (ICU) AND WAS ADMITTED FOR 3 DAYS BEFORE HE WAS STABILIZED. THE PATIENT REPORTED HE WAS DISCHARGED ON (B)(6) 2013 AND HIS FINAL DIAGNOSIS WAS DKA. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING AND WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLE. THE PATIENT'S TEST STRIPS AND TEST STRIPS VIAL WERE FOUND TO BE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL IN THE ER FOR A SEVERE COMPLICATION OF DIABETES. THERE IS NO INDICATION THAT THE SUBJECT METER MALFUNCTIONED SINCE THE TIME ELAPSED IN BETWEEN READINGS DID NOT MEET LFS' CRITERIA FOR PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50398 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3375272

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R