BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2771898 · Received October 4, 2012

    Report

    Report Number
    3008382007-2012-04762
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 14, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. LFS WILL EVALUATE THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE EVALUATED AND ER4 WAS OBSERVED WITH CONTROL SOLUTION TESTING. THE METER WAS EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIO IQ METER DISPLAYED AN 'ERROR 4' MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6), 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 3X DAILY. THE PATIENT MANAGES HER DIABETES WITH HUMULIN INSULIN (SLIDING SCALE) AND LANTUS INSULIN (8 UNITS 2X DAILY). THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT 8AM. THE PATIENT DENIED MAKING CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. A FEW DAYS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF TIRED, HANDS SHAKY AND NAUSEA. THE PATIENT DRANK ORANGE JUICE AS TREATMENT AND FELT BETTER ABOUT AN HOUR AFTER. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. THE CUSTOMER CARE ADVOCATE (CCA) WAS NOT ABLE TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3237613

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R