BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1915564 · Received December 6, 2010

    Report

    Report Number
    2939301-2010-10533
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/22/2010. 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. 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- 1/24/2011: 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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED A DRIVER SPRINT RAPID EXCHANGE 2.25 DIAMETER, 24 MM LENGTH STENT WAS ADVANCED TO A LESION IN THE LAD; HOWEVER, PRIOR TO INSERTION, THE STENT WAS DAMAGED DUE TO HANDLING. THERE WAS A RAISED STRUT THAT WAS FLATTENED BY A FINGER AND THE STENT WAS DEPLOYED IN THE PATIENT. NO PROBLEM WITH USE OF THE STENT. NO OTHER CLINICAL SEQUELAE HAVE BEEN REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT ON (B)(6) 2010, AT AROUND 1:00AM , HE TESTED HIS BLOOD GLUCOSE AND OBTAINED A 4.1 MMOL/L. HE DID NOT EXHIBIT ANY SYMPTOMS, AND HE TOOK SOME GLUCOZADE DUE TO THE READING. A FEW MINUTES LATER, HE FELT SICK AND PASSED OUT. WHEN HE REGAIN CONSCIOUSNESS, HE TOOK MORE GLUCOZADE AND A FEW MINUTES LATER TESTED HIS BLOOD GLUCOSE AGAIN AND OBTAINED A EITHER A 15.8 MMOL/L OR A 17.8 MMOL/L. A FEW MINUTES LATER, THE PARAMEDICS ARRIVED AND TESTED THE PATIENT ON THEIR METER AGAIN AND OBTAINED A 8.2 MMOL/L. A FEW MINUTES LATER THE PATIENT RETESTED ON HIS METER AND OBTAINED A 6.1 MMOL/L. THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT FROM THE PARAMEDICS. THE PATIENT FELT THAT THE READING OF 4.1MMOL/L WAS INACCURATE HIGH AND HAD IT BEEN LOWER, HE WOULD HAVE TAKEN MORE GLUCOZADE. THE PATIENT DID NOT HAVE THE METER OR TEST STRIPS AVAILABLE AT THE TIME OF THE CALL TO TROUBLESHOOT THE TESTING SUPPLIES. PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READING, HE HAD TAKEN GLUCOZADE AND A FEW MINUTES LATER HAD PASSED OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R