BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2434787 · Received February 1, 2012

    Report

    Report Number
    3008382007-2012-00239
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 26, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(6). THE 510 (K) # IS K093745.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PHARMACY CONTACTED LIFESCAN (LFS) (B)(4) ON BEHALF OF A PATIENT ALLEGING THAT A ONE TOUCH VERIO METER WOULD NOT TURN ON. ATTEMPTS BY LFS TO CONTACT THE PATIENT FOR FOLLOW-UP INFORMATION HAVE BEEN UNSUCCESSFUL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE PHARMACY: THE PATIENT INDICATED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT AN UNSPECIFIED TIME. THE PATIENT DENIED THAT HE TOOK ANY ACTIONS IN RELATION TO HIS USUAL ROUTINE OF DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. HE MANAGES HIS DIABETES WITH UNSPECIFIED PILLS WITH DIET AND/OR EXERCISE. ABOUT A DAY LATER, THE PATIENT CLAIMED THAT HE DEVELOPED "LOW SUGAR LEVELS" BECAUSE OF THE ALLEGED ISSUE. THE PATIENT DID NOT PROVIDE ANY SPECIFIC SIGNS OR SYMPTOMS OF LOW BLOOD GLUCOSE (BG). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT WENT TO A PHARMACY ON (B)(6) 2012, AT AN UNSPECIFIED TIME IN THE AFTERNOON. DUE TO HAVING HYPOGLYCEMIA, THE PHARMACY REPORTED TREATED THE PATIENT WITH A (B)(4). THE PHARMACY DENIED THAT THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE "LOW SUGAR LEVELS" DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT SPECIFIC SYMPTOMS (IF ANY) THE PATIENT DEVELOPED AND IF THE TREATMENT PROVIDED BY THE PHARMACY HELPED TO RELIEVE HIS ALLEGED HYPOGLYCEMIA. THE ALLEGED POWER ISSUE OF THE SUBJECT METER 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 PHARMACY CLAIMED THAT THE PATIENT DEVELOPED "LOW SUGAR LEVELS" AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED METER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R