BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 3113406 · Received May 15, 2013

    Report

    Report Number
    3008382007-2013-11553
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOPRO METER WAS READING INACCURATELY. MEDICAL SURVEILLANCE SENT FOLLOW-UP QUESTIONS; HOWEVER, CUSTOMER SERVICE (CS) WAS UNSUCCESSFUL IN REACHING THE PATIENT BY PHONE. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CS REPRESENTATIVE DURING THE PATIENT'S INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE BEGAN WHEN SHE WAS PREGNANT IN 2011 (DATE/TIME NOT SPECIFIED) AT WHICH TIME SHE WAS TESTING FOR APPROXIMATELY FIVE WEEKS. THE PATIENT'S TESTING FREQUENCY AND DIABETES REGIMEN ARE NOT KNOWN. ACCORDING TO THE CSR'S DOCUMENTATION, AT AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY OBTAINED A LOW BLOOD GLUCOSE READING WITH THE SUBJECT METER (RESULT NOT KNOWN), AND DESPITE THE LOW READING, THE PATIENT REPORTEDLY THEN ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN. IT IS NOT KNOWN IF THE PATIENT CONSUMED FOOD WITH HER INSULIN AND IT IS NOT CLEAR AT WHAT BLOOD GLUCOSE READING THE PATIENT WAS RECOMMENDED (BY HER PHYSICIAN) TO WITHHOLD THE INSULIN. PER CSR NOTES, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY BECAME DIZZY AND LOSS CONSCIOUSNESS "A COUPLE OF TIMES IN 2011" (DATES/TIMES NOT SPECIFIED). PRIOR TO THE LOSS OF CONSCIOUSNESS, THE PATIENT'S PREVIOUS BLOOD GLUCOSE READINGS ARE NOT KNOWN; IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE READINGS; AND IT IS NOT SPECIFIED IF THE PATIENT HAD MADE ANY CHANGES TO HER MEAL INTAKE, ACTIVITY LEVEL, OR DIABETES MANAGEMENT. IT IS NOT KNOWN WHAT TYPE OF MEDICAL INTERVENTION THE PATIENT RECEIVED AFTER THE ONSET OF HER SYMPTOMS AND IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOMS ABATED. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT ALSO CLAIMED HER PHYSICIAN ALSO "CHECKED THE METER AND FOUND THAT HER RESULTS ARE NOT CORRECT"; READINGS, HOWEVER, ARE NOT SPECIFIED. IT IS NOT CLEAR WHY THE PATIENT ONLY RECENTLY REPORTED THE ALLEGED METER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. A REPLACEMENT METER WAS SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT'S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214642 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