BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 3083636 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09395
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(6) 2013) - CORRECTION: FOR THE REPORT SUBMITTED ON (B)(6) 2013, THE FOLLOWING STATEMENT WAS INCLUDED IN THE CONCLUSION: ¿ THE ONETOUCH VERIO RECALL LETTER INVOLVES USERS OBTAINING LOW RESULTS WHEN THE BLOOD GLUCOSE IS OVER 1023 MG/DL. THE USER WOULD OBTAIN A RESULT THAT IS 1024 MG/DL LESS THAN WHAT THE METER ACTUALLY MEASURES. PATIENTS WITH SUCH HIGH BLOOD GLUCOSE WOULD NEED ADMISSION TO THE HOSPITAL AND WOULD NOT FEEL BETTER AFTER ONE SHOT OF INSULIN. THEREFORE, THIS CASE IS NOT RELATED TO THE RECALL ISSUE.¿ UPON A RETROSPECTIVE REVIEW OF THIS COMPLAINT, THE DIRECTOR OF MEDICAL AFFAIRS HAS CONCLUDED IT IS POSSIBLE THIS COMPLAINT COULD HAVE BEEN LINKED TO THE VERIO METER RECALL ISSUE. THEREFORE, PLEASE DISREGARD THE STATEMENT IN THE INITIAL REPORT SUBMITTED, SINCE IT CANNOT BE CONFIRMED THAT THE METER IS NOT LINKED TO THE RECALL ISSUE.

    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 HIS ONETOUCH VERIO PRO METER READ INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 8AM. THE PATIENT CLAIMS HE WOKE UP THAT MORNING FEELING A SYMPTOM OF DIZZY AND HAD "PAIN IN HIS KIDNEYS" WHICH HE ASSOCIATED WITH HIGH BLOOD GLUCOSE. THE PATIENT TESTED HIS BLOOD GLUCOSE AND OBTAINED A RESULT OF "155 MG/DL" WITH THE SUBJECT METER. IT IS NOT SPECIFIED HOW THE PATIENT MANAGES HIS DIABETES; HOWEVER, DENIED MAKING CHANGES TO HIS USUAL MANAGEMENT ROUTINE AT THAT TIME. THE PATIENT PROCEEDED TO EAT HIS BREAKFAST THAT MORNING. AFTER, THE PATIENT CLAIMED HE STARTED TO FEEL NAUSEA. MORE THAN 30 MINUTES AFTER TESTING WITH THE SUBJECT METER, THE PATIENT TESTED ON ANOTHER METER WHICH GAVE HIM A "HIGH GLUCOSE ALERT" MESSAGE. THE PATIENT CONTACTED THE HOSPITAL WHO ADVISED HIM TO ADMINISTER SELF INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT CONFIRMED HE HAS BEEN TAKING CORTISONE INJECTIONS WHICH ELEVATES HIS BLOOD GLUCOSE VALUES. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT WITH ANOTHER METER SUGGESTIVE OF A SERIOUS INJURY AND WAS ADVISED TO ADMINISTER INSULIN BY HIS HEALTH CARE PROFESSIONAL (HCP) AS TREATMENT. THERE IS ALSO EVIDENCE OF A POTENTIAL DELAY IN TREATMENT BASED ON THE ALLEGED LOW BLOOD GLUCOSE RESULT OBTAINED WITH THE SUBJECT METER. THE ONETOUCH VERIO RECALL LETTER INVOLVES USERS OBTAINING LOW RESULTS WHEN THE BLOOD GLUCOSE IS OVER 1023 MG/DL. THE USER WOULD OBTAIN A RESULT THAT IS 1024 MG/DL LESS THAN WHAT THE METER ACTUALLY MEASURES. PATIENTS WITH SUCH HIGH BLOOD GLUCOSE WOULD NEED ADMISSION TO THE HOSPITAL AND WOULD NOT FEEL BETTER AFTER ONE SHOT OF INSULIN. THEREFORE, THIS CASE IS NOT RELATED TO THE RECALL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185136 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3278787

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R