BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1832534 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07794
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529.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 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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY REPORTER / SISTER CONTACTED LFS ON SEPTEMBER 1, 2010 ALLEGING INACCURATE HIGH READINGS ON HER SISTER'S ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON SEPTEMBER 1, 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT ON (B)(6) 2010 AT 1:00PM, SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A RESULT OF 90 MG/DL. SHE TOOK HER USUAL DOSAGE OF GLYPIZIDE AND ACTOSE. SHE STARTED TO MAKE LUNCH AND 10 MINUTES LATER, HER HANDS STARTED TO SHAKE UNCONTROLLABLY. SHE WAS ALSO NOT MAKING ANY SENSE WHEN THE REPORTER WAS TALKING TO HER. REPORTER DID NOT ATTEMPT TO TREAT THE PATIENT OR ATTEMPT TO TEST HER BLOOD GLUCOSE AGAIN. THE SYMPTOMS WERE NOT GOING AWAY AND THE REPORTER DECIDED TO CONTACT THE PARAMEDICS AROUND 4:00PM. WHEN THE PARAMEDICS ARRIVED, THE PATIENT'S BLOOD GLUCOSE WAS 30 MG/DL ON THE PARAMEDIC'S METER AND SHE WAS TREATED WITH A GLUCAGON INJECTION. THE PATIENT WAS TAKEN IN THE ER AND WAS THERE FOR A COUPLE OF HOURS PRIOR TO BEING DISCHARGED. PATIENT DOES NOT RECALL WHAT HER READING WAS PRIOR TO BEING RELEASED FROM THE ER. THE DIAGNOSES WERE THE FOLLOWING PER THE PATIENT: "HYPOGLYCEMIA, ANEMIA AND LOW POTASSIUM". PATIENT'S DIABETES REGIMEN WAS CHANGED. HER GLIPIZIDE WAS CHANGED FROM TWICE A DAY TO ONCE DAY AND ACTOSE WAS INCREASED TO 3X A DAY. THE PATIENT WAS ALSO GIVEN ANEMIA MEDICATION AND HER POTASSIUM MEDICATION WAS DECREASED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING ON HER LFS METER, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT FOR A LOW BLOOD GLUCOSE READING OF 30 MG/DL ON THE PARAMEDIC'S METER.

    Description of Event or Problem · 1

    ALLEGEDLY, THE COMPONENT REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3022332

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R