BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2413927 · Received January 12, 2012

    Report

    Report Number
    3008382007-2012-00089
    Event Type
    Injury
    Date Received
    January 12, 2012
    Report Date
    December 14, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    FOLLOW-UP # 1 ((B)(4) 2012)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED AND FOUND TO HAVE FAILED FOR CONTROL SOLUTION HIGH AND ER4 WAS ALSO OBSERVED. 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 USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH VERIO PRO METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE PATIENT WAS UNSUCCESSFUL TO BE REACHED. MSS DOCUMENTED THE COMPLAINT BASED ON THE INITIAL REPORT. ON AN UNSPECIFIED DATE AND TIME, THE PATIENT DEVELOPED SYMPTOMS OF FEELING TIRED AND NERVOUS WHICH SHE CONCERNS OF LOW BLOOD SUGAR. SHE THEN TESTED HER BLOOD GLUCOSE AND OBTAINED AN ALLEGED HIGH READING. RESULT WAS NOT PROVIDED. DUE TO THE ALLEGED HIGH READING, SHE TOOK MORE INSULIN AND AT AN UNSPECIFIED TIME LATER HER SYMPTOMS WORSENED. PER THE INITIAL CALL THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PRODUCT WAS REPLACED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS AT THE TIME OF THE EVENT, CONFIRM HOW MUCH INSULIN THE PATIENT HAD TAKEN, HOW SOON AFTER THE PATIENT SYMPTOMS GOT WORSE AND TO CONFIRM WHETHER OR NOT THE PATIENT TREATED AND HOW SOON AFTER THE PATIENT FELT BETTER. THE PRODUCT WAS REPLACED AND REQUESTED BACK. AT THIS TIME, THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO SHE HAD DEVELOPED SYMPTOMS AND TESTED AND ALLEGEDLY OBTAINED A HIGH READING, TOOK MORE INSULIN AND LATER HER SYMPTOMS GOT WORSE.

    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 3207678

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening