BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2760033 · Received September 26, 2012

    Report

    Report Number
    2939301-2012-11097
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT (HER HUSBAND) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATE RESULTS 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) 2012. ON (B)(6) 2012 BETWEEN 4-5PM, THE REPORTER STATED THE PATIENT OBTAINED READINGS OF "160, 290 AND 310MG/DL" ON HIS LFS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE RESULTS IS GREATER THAN THE EXPECTED VALUE OF <=20% OR<=20MG/DL. THE PATIENT REPORTED HE TAKES 70/30 INSULIN ON A SLIDING SCALE AND LANTUS 20 UNITS AT BEDTIME. THE PATIENT DENIED TAKING ANY ORAL MEDICATIONS TO MANAGE HIS DIABETES. THE PATIENT REPORTED HE NORMALLY TESTS 3 TIMES A DAY AND HIS NORMAL RESULTS ARE LESS THAN 150MG/DL. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED HE TOOK HIS DOSE OF 70/30 INSULIN AS USUAL DESPITE THE VARYING BLOOD GLUCOSE READINGS. THE PATIENT REPORTED TO THE MSS ON (B)(6) 2012 IN THE EVENING HE "PASSED OUT JUST FOR A MOMENT" AND HIT HIS HEAD ON THE FLOOR AND WAS BLEEDING PROFUSELY FROM A HEAD LACERATION. THE PATIENT REPORTING REVIVING ON HIS OWN, BUT HIS WIFE CALLED EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT REPORTED HE HAD NEVER FALLEN PREVIOUSLY. THE PATIENT REPORTED HE WAS IMMEDIATELY TAKEN BY AMBULANCE TO THE EMERGENCY ROOM (ER). EN ROUTE TO THE ER, THE PATIENT REPORTED READINGS OF "65-66MG/DL" WERE OBTAINED ON THE EMS METER AND NO TREATMENT WAS ADMINISTERED. THE PATIENT REPORTED ANOTHER LOW BLOOD GLUCOSE READING WAS OBTAINED IN THE ER, BUT COULD NOT RECALL THE READING. THE PATIENT CONFIRMED HE WAS NOT GIVEN ANY IV GLUCOSE OR FOOD FOR 3.5 HOURS. THE PATIENT REPORTED THAT THE DOCTOR COULD NOT FIND THE CAUSE OF THE FALL AND HE HAS A LASTING SPEECH IMPEDIMENT, BUT CONFIRMED HE DID NOT SUFFER A STROKE. THE PATIENT REPORTED HE WAS DISCHARGED ON THE SAME DAY. THE PATIENT REPORTED THAT HE BELIEVED THE FALL WAS A RESULT OF LOW BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE PATIENT'S TESTING PROCESS WAS CORRECT, HOWEVER THE PATIENT'S TEST STRIPS WERE EXPIRED. THE PATIENT REPORTED THE HOSPITAL DISPOSED OF THE TEST STRIPS, THEREFORE HE DID NOT HAVE ANY TO RETURN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED HE OBTAINED INACCURATE READINGS AND TOOK HIS DOSE OF INSULIN AS USUAL, AND LOSS CONSCIOUSNESS AFTER THE ISSUE BEGAN. HOWEVER THE PATIENT'S METER VS. SAME METER COMPARISON IS INVALID SINCE THE PATIENT'S TEST STRIPS WERE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3039306

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R