BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5418643 · Received February 9, 2016

    Report

    Report Number
    2939301-2016-06051
    Event Type
    Injury
    Date Received
    February 9, 2016
    Report Date
    February 5, 2016
    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
    MA, US
    Reporter Occupation
    PATIENT

    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.THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER 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

    FOLLOW-UP #1. THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS AND METER BOTH PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT; IT CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. 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 FEBRUARY 5, 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HER ONETOUCH VERIO IQ METER READ BLOOD AS CONTROL SOLUTION. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ABOUT A MONTH PRIOR TO CONTACTING LIFESCAN (DATE/TIME NOT PROVIDED). THE PATIENT STATED THAT SHE OBTAINED THE RESULTS OF "134, 113, 135, 121, 150, 158, 221 AND 145 MG/DL" USING THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH ORAL DIABETES MEDICATIONS WITH DIET AND/OR EXERCISE. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF GLIPIZIDE (2.5 MG DAILY) AND METFORMIN (1 G TWICE DAILY) MEDICATION (INCLUDING SLIDING SCALE) ON (B)(6) 2016 AT AROUND 10:30-11AM. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "LOSS OF VISION" APPROXIMATELY 3 WEEKS AFTER THE ALLEGED PRODUCT ISSUE BEGAN; HOWEVER SHE DENIED THAT SHE RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE ALLEGED PRODUCT ISSUE WAS RESOLVED WITH A WALK-THROUGH RETEST, THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN FOR LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY AND THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "LOSS OF VISION" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78054 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3847812

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening