BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4053378 · Received September 3, 2014

    Report

    Report Number
    2939301-2014-22709
    Event Type
    Injury
    Date Received
    September 3, 2014
    Report Date
    August 22, 2014
    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
    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 # 2 ¿ (11/11/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/23/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 11/04/2014 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 ¿ (09/29/2014), THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 9/17/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/18/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE 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 REPORTER CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT THE ALLEGED INACCURACY ISSUE FIRST OCCURRED AT AN UNKNOWN TIME ¿SOME WEEKS AGO¿. THE REPORTER WAS UNABLE TO PROVIDE ANY SPECIFIC METER READINGS WHICH WERE OBTAINED AT THIS TIME. THE REPORTER STATED THAT THE PATIENT MANAGES THEIR DIABETES WITH AN ¿INSULATARD FLEXPEN¿ AND ADJUSTS THEIR DOSE BASED ON SUBJECT METER READINGS. THE PATIENT HAD RECEIVED TELEPHONE ADVICE FROM A HEALTHCARE PROFESSIONAL (HCP) TO PROGRESSIVELY INCREASE THEIR DOSAGE OF INSULIN FROM 2 UNITS PER DAY, AND HAD BEEN PROGRESSIVELY DOING SO SINCE (B)(6) 2014. THE CSR NOTED THAT THE PATIENT INCREASED THEIR DOSE BY 1 UNIT EVERY 3 DAYS, AND IS CURRENTLY TAKING 15 UNITS PER DAY, DESPITE THE PATIENT FEELING AS THOUGH THEY ARE CURRENTLY TAKING TOO MUCH. AT AN UNKNOWN TIME AFTER THE PRODUCT ISSUE STARTED THE REPORTER STATED THAT THE PATIENT SUFFERED SYMPTOMS OF ¿BLURRY VISION, VERTIGO AND SHAKY¿ WHICH ARE SUGGESTIVE OF SEVERE HYPOGLYCEMIA. AFTER FEELING THESE SYMPTOMS THE PATIENT ATE SUGAR ON THE ADVICE OF HER SPOUSE (A HCP) AND CLAIMED TO FEEL BETTER ¿HALF AN HOUR¿ LATER. A BLOOD GLUCOSE TEST WAS PERFORMED ON A ONETOUCH VITA METER AT AN UNKNOWN TIME, HOWEVER RESULTS COULD NOT BE RECALLED AT THIS TIME. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND AN APPROVED SAMPLE SITE WAS BEING USED. HOWEVER, THE TEST STRIPS BEING USED WERE OPEN LONGER THAN THEIR DISCARD DATE. THE PRODUCTS WERE REQUESTED BACK FOR EVALUATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THAT THE PATIENT OBTAINED INACCURATELY ERRATIC READINGS ON THE SUBJECT METER, INCREASED HER DOSE OF INSULIN BASED ON THESE READINGS AND THEN SUFFERED SYMPTOMS WHICH ARE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538565 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3639374

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening