BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3040904 · Received April 8, 2013

    Report

    Report Number
    3008382007-2013-07219
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/22/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/13/2013 AND 9/13/2013, RESPECTIVELY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, LIFESCAN SALES REPRESENTATIVE CONTACTED LIFESCAN (LFS) TO REPORT THAT A DIABETES EDUCATOR CLAIMED THAT THEIR PATIENT'S ONETOUCH VERIO METER WAS ALLEGEDLY READING INACCURATELY LOW COMPARED TO MULTIPLE METERS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE BEGAN. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF "2.8MMOL/L" WITH THE SUBJECT METER, "5.3MMOL/L" WITH THE UPTIMUM EXCEED METER, "5.4MMOL/L" WITH THE PERFORMA METER, AND "4.7MMOL/L" WITH THE DIABETES EDUCATOR'S ONETOUCH VERIO METER; PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THERE IS NO INDICATION THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE AND THERE IS NO EVIDENCE THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE SALES REPRESENTATIVE DID NOT HAVE ANY OF THE PATIENT'S TESTING SUPPLIES AVAILABLE. REPLACEMENT METER WAS GIVEN TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO OTHER METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143880 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1