BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2222198 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-08000
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K001109. 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

    FOLLOW-UP # 1 ((B)(4) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4), 2011 THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PINS 1-3 BENT. ON (B)(4), 2011 THE TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY REPORTER WIFE CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE READINGS ON HER HUSBAND'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE REPORTER MENTIONED THAT ON THE EVENING OF (B)(6) 2011, THE PATIENT HAD TESTED ON THEIR METER; HOWEVER READING WAS NOT PROVIDED. THE PATIENT TOOK THEIR USUAL DOSAGE OF ORAL MEDICATION, GLYBURIDE AND METFORMIN AND APPROXIMATELY FOUR HOURS LATER THAT EVENING THE PATIENT HAD PASSED OUT. THE WIFE TESTED HIS BLOOD GLUCOSE AND OBTAINED A 134 MG/DL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BENE HELPFUL TO KNOW HOW SOON AFTER THE PATIENT REGAINED CONSCIOUSNESS, AND TO VERIFY WHETHER OR NOT THERE WAS ANY OTHER TREATMENT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE METER RESULT, THE PATIENT HAD TAKEN THEIR ORAL MEDICATION OF GLYBURIDE AND METFORMIN AND APPROXIMATELY 4 HOURS LATER PASSED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3170531

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening