BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2241142 · Received September 9, 2011

    Report

    Report Number
    3008382007-2011-00360
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 31, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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. LOT # WAS NOT PROVIDED. THE 510 (K) # IS K093745.

    Description of Event or Problem · 1

    THE PHARMACIST CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THE PATIENT'S ONE TOUCH VERIO PRO METER COMPARED TO A CONTOUR METER. THE PHARMACIST STATED THAT THE PATIENT HAD OBTAINED A 14 MMOL/L (252 MG/DL) ON THE VERIO METER AND LESS THAN 30 MINUTES LATER TESTED ON A CONTOUR METER AND OBTAINED A 9 MMOL/L (162 MG/DL). THE PHARMACIST WAS IN A HURRY AND WAS UNABLE TO TROUBLESHOOT. THE CUSTOMER CARE ADVOCATE (CCA) CONTACTED THE PATIENT AND THE PATIENT MENTIONED THAT EVERYTHING WAS OK AND THAT HE CONTACTED HIS PHYSICIAN AND THE PHYSICIAN ADVISED THAT THE PATIENT ADJUST HIS INSULIN BASED ON THE METER READING. THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT DID NOT REPORT ANY SYMPTOMS AND ADJUSTED THE INSULIN ACCORDINGLY TO THE METER READING. THE COMPLAINT IS BEING REPORTED SINCE THE DIFFERENCE BETWEEN THE TWO METER READINGS IS GREATER THAN 30 MG/DL (1.7 MMOL/L) OR 30%.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1