BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3132627 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13387
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 22, 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
    BE
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIOPRO METER READ INACCURATELY. THE CUSTOMER CARE ADVOCATE (CCA) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION DURING THE INITIAL CALL. THE ALLEGED ISSUE BEGAN ABOUT A YEAR PRIOR TO CONTACTING LFS. THE PATIENT ALLEGED HIS BLOOD GLUCOSE ¿DEGRADED HIGHLY;¿ HOWEVER SPECIFIC RESULTS WERE NOT PROVIDED FROM THE SUBJECT METER. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. THE PATIENT CLAIMED HE HAD SEVERAL INSTANCES WHEN HE FELT ¿FAINTNESS¿ AND DIZZINESS. THE PATIENT REPORTEDLY SAW HIS PHYSICIAN/ SPECIALISTS AND HAD BLOOD TESTS PERFORMED. NO ADDITIONAL TREATMENT WAS SPECIFIED. BETWEEN (B)(6) 2013, THE PATIENT REPORTED COMPARING VARIOUS RESULTS BETWEEN ¿58 TO 232 MG/DL¿ WITH THE SUBJECT METER AND ¿51 TO 197 MG/DL¿ WITH ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO METER ACCURACY TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. 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. THE PATIENT'S REPORTED SYMPTOMS OF ¿FAINTNESS AND DIZZINESS" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234982 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388314

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR