BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3961234 · Received July 28, 2014

    Report

    Report Number
    2939301-2014-18811
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 21, 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
    FR
    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 # 1 ¿ (10/08/2014), THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 09/24/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/06/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE PRIMARY COMPLAINT COULD NOT BE 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), 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH VERIO IQ METER DISPLAYED A BATTERY INDICATOR. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2014 (TIME NOT SPECIFIED). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, AFTER THE ALLEGED POWER ISSUE OCCURRED, THE PATIENT DENIED TAKING ACTION IN REGARDS TO HIS DIABETES REGIMEN AND ALSO DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE ALLEGED POWER ISSUE, THE PATIENT REPORTEDLY DEVELOPED HYPERGLYCEMIC SYMPTOMS OF ¿FEELING HUNGRY, THIRSTY, AND MOUTH DRY¿ ON (B)(6), 2014. ON (B)(6), 2014, THE PATIENT REPORTEDLY ADMINISTERED BETWEEN 2-3 UNITS OF INSULIN (EVERY 2 HOURS) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439373 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3618077

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R