BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2492104 · Received March 15, 2012

    Report

    Report Number
    3008382007-2012-00755
    Event Type
    Injury
    Date Received
    March 15, 2012
    Report Date
    February 28, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    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) #K093745. LOT # OF TEST STRIPS AND SERIAL NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE PHARMACIST CONTACTED LIFESCAN (LFS) ON (B)(6) 2012 ALLEGING INACCURATE READINGS ON THE PATIENT'S ONE TOUCH VERIO PRO METER COMPARED TO A ONE TOUCH ULTRA EASY METER. THE PATIENT WAS NOT IN THE PHARMACY AT THE TIME OF THE CALL. THE FOLLOWING INFORMATION WAS CLASSIFIED BASED ON THE INITIAL CALL. THE PHARMACIST MENTIONED THAT THE PATIENT HAD OBTAINED A RESULT OF 97 MG/DL ON HIS ONE TOUCH VERIO PRO METER AND AN 80 MG/DL ON HIS ONE TOUCH ULTRA EASY METER. THE READINGS WERE TAKEN WITHIN MINUTES FROM ONE ANOTHER. THE DIFFERENCE BETWEEN THE TWO RESULTS WAS 21.3%. PHARMACIST MENTIONED THAT THE PATIENT HAS NEVER READ THE OWNER'S BOOKLET AND DID NOT KNOW HOW TO USE CONTROL SOLUTION TO CHECK THE METER. THE CUSTOMER CARE ADVOCATE (CCA) TRAINED THE PHARMACIST ON HOW TO PROPERLY USE THE METER AND HOW TO RUN A QUALITY CONTROL TEST. THE PHARMACIST MENTIONED THAT DUE TO THE UNUSUAL READING, THE PATIENT HAD OBTAINED, HE HAD CHANGED HIS INSULIN DOSAGE AND SOMETIME IN THE MONTH OF (B)(6), HE DEVELOPED SYMPTOMS OF "HYPOGLYCEMIA." PHARMACIST COULD NOT PROVIDE ANY FURTHER CLINICAL INFORMATION. IT WOULD HAVE BEEN HELPFUL TO KNOW EXACT SYMPTOMS, READINGS, HOW MUCH INSULIN HE HAD TAKEN, WHETHER HE SELF-TREATED AND HOW LONG SYMPTOMS LASTED. THE COMPLAINT IS BEING REPORTED SINCE THE PHARMACIST ALLEGED THAT DUE TO THE ALLEGED HIGH READING ON HIS VERIO PRO METER, THE PATIENT HAD HIS INSULIN AND AT AN UNSPECIFIED TIME LATER DEVELOPED "HYPOGLYCEMIA."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening