BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2488391 · Received March 12, 2012

    Report

    Report Number
    3008382007-2012-00707
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 8, 2012
    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

    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 510 (K) # IS K093745.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE LOOSE/BROKEN CONTACTS. 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

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (B)(4) ALLEGING A POWER ISSUE WITH A ONE TOUCH VERIO METER. THE PATIENT CLAIMED THAT THE METER WOULD NOT POWER ON. SHE MANAGES HER DIABETES WITH SELF-ADJUSTED INSULIN (UNSPECIFIED TYPE). THE PATIENT INDICATED THAT THE ALLEGED POWER ISSUE BEGAN ON (B)(6) 2012, AT 9:00 PM. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED "HYPO" SYMPTOMS OF HUNGER, SHAKINESS, DIZZINESS, AND BLACKING OUT. AT AN UNSPECIFIED TIME DURING THE TIME OF CONCERN, THE PATIENT'S BLOOD GLUCOSE (BG) WAS TESTED ON A NEIGHBOR'S METER AND A RESULT OF "3.0 MMOL/L" WAS OBTAINED. AT 9:30 AM THAT SAME MORNING, THE PATIENT ADMINISTERED SELF-CARE BY EATING SWEETS. WITHIN A HALF OUR AFTER THE SYMPTOMS BEGAN, THE PATIENT CLAIMED THAT THE SYMPTOMS GOT WORSE. IT IS UNKNOWN WHAT TIME THE PATIENT BEGAN TO FEEL BETTER AND WHAT TIME HER SYMPTOMS WERE RELIEVED. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED POWER ISSUE WITH THE METER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening