BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 4133981 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26060
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    September 24, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/19/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 11/13/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/8/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIO PRO METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY (B)(6) 2014. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2014. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED HE OBTAINED A READING WITH THE SUBJECT METER THAT WAS INACCURATE COMPARED TO A READING FROM ANOTHER DEVICE. THE PATIENT DID NOT PROVIDE THE ACTUAL READINGS OBTAINED WITH THE SUBJECT METER OR ON THE OTHER DEVICE. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NOVORAPID, SELF-ADJUSTER; LANTUS, 31 UNITS AT BEDTIME). AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED HE WENT INTO HIS DOCTOR¿S OFFICE FOR A ROUTINE APPOINTMENT AND HIS HEALTH CARE PROFESSIONAL (HCP) INCREASED HIS MEDICATION DOSAGES TO ¿NOVORAPID- 10 UNITS IN THE MORNING, 24 UNITS AT LUNCH, 24 UNITS IN THE EVENING AND LANTUS- 34 UNITS AT NIGHT¿. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OR RECEIVING ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616632 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR