BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1894509 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09764
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 28, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510K #K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT (B)(4) 2010. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 12/10/2010: THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING INACCURATE ERRATIC READINGS OF "314, 153, AND 108 MG/DL." ON (B)(6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST OBTAINED FOLLOW-UP INFORMATION FROM THE PATIENT DURING A CALL BACK SESSION. THE PATIENT'S DIABETES IS MANAGED WITH METFORMIN ORAL MEDICATION. AROUND (B)(6) 2010, THE PATIENT OBTAINED THE ALLEGED ERRATIC READINGS AT 11 PM. HE FELT THE "314 MG/DL" BLOOD GLUCOSE READING WAS INACCURATELY HIGH AT THE TIME OF CONCERN. HE CLAIMED THAT THE ALLEGED READINGS OF "314, 153, AND 108 MG/DL" DID NOT HAVE ANY THING TO DO WITH THE ALLEGED LOW SYMPTOMS HE EXPERIENCED A FEW DAYS AFTERWARDS. ON THE DAY OF THE HYPOGLYCEMIC EPISODE, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "100 AND 130 MG/DL" ON THE SUBJECT METER AT 7 AM. THE PATIENT TOOK HIS USUAL 1000 MG OF METFORMIN ON THE DAY OF CONCERN AND ATE HIS BREAKFAST. THE PATIENT CLAIMED THAT HE DEVELOPED LOW BLOOD SYMPTOMS DESCRIBED AS "SWEATY, SHAKY, AND SICK" AT 10 AM. HE TESTED ON ANOTHER DEVICE AT HIS WORK PLACE AND OBTAINED BLOOD GLUCOSE READING OF "46 MG/DL." THERE WAS NO READING TAKEN ON THE SUBJECT METER AT THE TIME OF CONCERN AS THE PATIENT REPORTEDLY DOES NOT BRING HIS METER TO WORK. THE PATIENT ALLEGEDLY ADMINISTERED SELF TREATMENT WITH FOOD/DRINK AND FELT BETTER SOON AFTER. THE PATIENT EXPRESSED THAT HE DOES NOT KNOW HOW THE ALLEGED HYPOGLYCEMIC EPISODE COULD HAVE BEEN PREVENTED AND INDICATED THE ALLEGED "130 MG/DL" MAY HAVE BEEN INACCURATELY HIGH. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE REPORTED METER READINGS OF "314, 153, AND 108 MG/DL" WERE TAKEN WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER OBTAINING AN ALLEGEDLY ELEVATED READING ON THE LFS METER.

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: PT WAS ADMITTED TO THE HOSPITAL FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE CLIPPING OF THE CYSTIC DUCT. THE CLIP MISFIRED TWO TO THREE TIMES CAUSING AN INCOMPLETE CLOSURE WHICH RESULTED IN MACERATED CYSTIC DUCT. THE SURGEON HAD TO USE A HARMONIC SCALPEL IN AN UNCONVENTIONAL FASHION AND SEARED THE DUCT CLOSED. AS THE SURGEON REMOVED THE STAPLER, IT GOT STUCK IN THE PORT AND BROKE AS IT CAME OUT. THE SURGEON DISCONTINUED USING THE CLIPS ON THE CYSTIC ARTERY AND USED THE HARMONIC SCALPEL INSERTED. EVENT ABATED AFTER USE: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN SCUBA DIVING IN 18 FEET OF WATER. SHORTLY AFTER COMING OUT OF THE WATER, WAS TALKING WITH COMPANIONS AND PATIENT SUDDENLY COLLAPSES. THE PATIENT DIED (B)(6) 2010. ADDITIONAL INFORMATION AND THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3033712

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R