BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3173372 · Received June 17, 2013

    Report

    Report Number
    3008382007-2013-17473
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - PRODUCT EVALUATION: THE SUBJECT METER AND ASSOCIATED TEST STRIPS WERE RETURNED ON (B)(4) 2013 AND ANALYSES COMPLETED ON (B)(4) 2013, RESPECTIVELY BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. THE METER AND TEST STRIPS MET SPECIFICATIONS FOR TESTING. NO ISSUES WERE IDENTIFIED DURING INVESTIGATION. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING THE ERROR 4 ERROR MESSAGE DURING TESTING. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, AT 6:00 AM, THE PATIENT OBTAINED THE ERROR 4 ERROR MESSAGE ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. THIRTY MINUTES AFTERWARDS, THE PATIENT LOST CONSCIOUSNESS. THE PATIENT¿S VISITING NURSE TOOK THE PATIENT TO THE EMERGENCY ROOM, WHERE HER BLOOD GLUCOSE LEVEL WAS TESTED TO BE 1.7 MMOL/L. THE PATIENT WAS TREATED WITH FOOD AND/OR A DRINK. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. TROUBLESHOOTING REVEALED THE PATIENT¿S TESTING TECHNIQUE WAS INCORRECT, WHICH CAN CAUSE ERROR MESSAGES TO OCCUR. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND PATIENT EDUCATION. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT, WHICH MAY HAVE CONTRIBUTED TO THE ERROR MESSAGE. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE OCCURRED, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273842 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3423095

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R