BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3244001 · Received July 24, 2013

    Report

    Report Number
    3008382007-2013-20825
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    July 8, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    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 (08/13/2013)-PRODUCT EVALUATION: THE PATIENT¿S TEST STRIPS WERE RETURNED ON 07/30/2013 AND ANALYSIS COMPLETED ON 08/07/2013 BY LIFESCAN PRODUCT ANALYSIS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS OBSERVED. ERROR 4 MESSAGE WAS OBSERVED WHEN THE TEST STRIPS WERE ANALYZED USING CONTROL SOLUTION. 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) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT¿S ONETOUCH VERIOPRO METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 5 MONTHS PRIOR TO CONTACTING LFS. IT WAS REPORTED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS ¿OVER 4¿ MG/DL WITH THE SUBJECT METER. SPECIFIC RESULTS WERE NOT PROVIDED. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. AT AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY VISITED HIS PHYSICIAN¿S OFFICE. THE PATIENT¿S BLOOD GLUCOSE WAS TESTED AT THE PHYSICIAN¿S OFFICE; HOWEVER, RESULTS OBTAINED WITH THE PHYSICIAN¿S METER WERE NOT PROVIDED. THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS DUE TO THE REPORTED ISSUE. NO ADDITIONAL TREATMENT WAS SPECIFIED. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346376 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3398899

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR