BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3132561 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13169
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (1/27/2014)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/10/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIP 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

    FOLLOW-UP # 2 ¿ (02/20/2014) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 AND (B)(4) 2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO BE UNABLE TO REPRODUCE AN ERROR 2 MESSAGE. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE METER'S TEST STRIP HOLDER J2 WAS FOUND TO BE DEFECTIVE. 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIO METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013 (AT 5 PM). IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF DIZZINESS AND FELT LIKE HER HEAD WAS SPINNING AT AN UNKNOWN TIME LATER THAT DAY. THE PATIENT, HOWEVER, DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT TEST STRIPS AT THE TIME OF THE ALLEGED ISSUE AND SHE WAS USING THE PROPER TESTING TECHNIQUE (PER OWNER¿S BOOKLET RECOMMENDATION). THE CSR ALSO NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236377 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3400283

    Patients

    Seq Age Sex Outcome Treatment
    1