BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2082968 · Received May 10, 2011

    Report

    Report Number
    2939301-2011-03840
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (06/09/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (06/03/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1- 07/20/2011. ADDITIONAL INFORMATION: SUBMITTING IMPORTER INFORMATION FOR SECTION F AND THE UF/IMPORTER # THAT WAS NOT INCLUDED IN THE INITIAL MDR.

    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. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510 (K) # IS K093745.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN "ERROR 2" ISSUE WITH A ONE TOUCH VERIO METER. THE PATIENT INDICATED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011, AT AN UNSPECIFIED TIME. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY EXERCISED ON (B)(6) 2011, AT AN UNKNOWN TIME. THAT SAME DAY, THE PATIENT CLAIMED THAT HE DEVELOPED A SYMPTOM OF FEELING A "LITTLE SHAKY". THE PATIENT ALLEGED THAT THE SYMPTOM DEVELOPED BECAUSE HE WAS STARTING TO TAKE INSULIN DURING THE TIME OF CONCERN AND WAS NOT ABLE TO TEST HIS BLOOD GLUCOSE (BG). THE PATIENT DENIED THAT HE RECEIVED ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. SEVERAL ATTEMPTS HAVE BEEN MADE UNSUCCESSFULLY TO CONTACT THE PATIENT FOR FOLLOW-UP QUESTIONING. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHEN THE PATIENT STARTED THE REPORTED INSULIN REGIMEN, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOM DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT TIME THE PATIENT EXERCISED ON (B)(6) 2011, WHAT TIME THE SYMPTOM DEVELOPED, WHAT TIME THE SYMPTOM WAS RELIEVED, IF THE PATIENT ATTRIBUTED THE SYMPTOM OF SHAKINESS TO DIABETES OR ANOTHER HEALTH CONDITION, AND IF THE PATIENT WAS ABLE TO TEST HIS BG ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE ALLEGED ERROR 2 ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3052022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening