BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3811566 · Received May 15, 2014

    Report

    Report Number
    2939301-2014-11472
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    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

    FOLLOW-UP # 2 (9/12/2014) - DEVICE EVALUATION: THE RETAIN TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. ADDITIONALLY THE METER DHR PASSED WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - (06/20/2014), THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT YET BEEN RETURNED TO LIFESCAN FOR PRODUCT ANALYSIS EVALUATION. THE RETAIN TEST STRIPS FAILED THE PERFORMANCE TESTING WITH CONTROL SOLUTION AT LEVEL 300. 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) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH VERIO IQ METER IS GIVING AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SET AMOUNT EACH DAY). THE METER ALLEGEDLY STOPPED WORKING ON (B)(6) 2014, AT AROUND 6:30 AM. FOR 3 DAYS, THE PATIENT REPORTEDLY COULD NOT TEST HER BLOOD GLUCOSE READING. ON (B)(6) 2014, THE PATIENT HAD A HEADACHE AND FELT THIRSTY. SHE MENTIONED THE REPORTED SYMPTOMS ARE USUALLY HOW SHE FEELS WHEN HER BLOOD GLUCOSE IS ¿TOO LOW.¿ SHE THOUGHT HER BLOOD GLUCOSE LEVEL WAS AROUND 4.9 MMOL/L AT THE TIME OF CONCERN. IN ADDITION, SHE STATED SHE DID NOT LOSE CONSCIOUSNESS; HOWEVER, SHE EXPERIENCED MILD SWEATINESS AND SHAKINESS. THE SYMPTOMS ABATED WITH ORAL MEDICATION (TYLENOL). THE UNKNOWN ERROR ISSUE WAS NOT IDENTIFIED AND COULD NOT BE RESOLVED DURING TRAINING. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ERROR MESSAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291886 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3606596

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening