BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3934834 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17439
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    July 9, 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

    FOLLOW-UP # 2 ¿ (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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/19/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 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.

    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. DATE OF EVENT NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE CONTACTED THE PATIENT TO OBTAIN AND CLARIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, DIZZINESS AND BLURRED VISION. THE PATIENT CONTACTED HER HCP FOR ASSISTANCE/ADVICE, AND WAS ADVISED TO CONSUME FOOD AND SODA, WHICH SHE DID. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. ON (B)(6) 2014 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 96 MG/DL ON THE REPORTED METER AND A LABORATORY RESULT OF 74 MG/DL WITHIN 10 MINUTES. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE PATIENT FELT BETTER AFTER CONSUMING THE FOOD, IF SHE TESTED HER BLOOD GLUCOSE LEVEL WITH THE REPORTED METER WHILE SYMPTOMATIC AND WHAT THAT RESULT WAS, HER BLOOD GLUCOSE READINGS AND INSULIN DOSES TAKEN PRIOR TO THE ONSET OF SYMPTOMS. TROUBLESHOOTING REVEALED THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA WHILE USING THE REPORTED METER, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE HER SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413905 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3602264

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R