BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA ENHANCED METER

    MDR report key: 3946149 · Received July 21, 2014

    Report

    Report Number
    2939301-2014-18023
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 15, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (09/02/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/20/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/21/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. TERTIARILY, THE TEST STRIPS WERE FOUND TO BE CONTAMINATED. QUATERNARILY, WHEN TEST STRIPS WERE TESTED WITH CONTROL SOLUTION, AN ERROR 5 WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THEIR ONETOUCH VITA ENHANCED METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE¿S DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT AN UNSPECIFIED TIME AT NIGHT; HE ATTEMPTED TO USE THE SUBJECT METER AND WAS UNABLE TO. THE PATIENT CLAIMED AT AN UNKNOWN TIME THAT NIGHT, HE DEVELOPED LOW BLOOD GLUCOSE SYMPTOMS OF ¿TREMBLING AND FLUSH FEELING.¿ HE DID NOT ADMINISTER ANY FORM OF TREATMENT FOR HIS SYMPTOMS. THE PATIENT REPORTED THAT HE IS AN INSULIN USER (UNKNOWN TYPE/DOSE) AND IT¿S NOT KNOWN IF HE MADE CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED ISSUE. NO OTHER DEVICE WAS AVAILABLE TO USE FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING; THE METER WAS REPLACED AND EXPECTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424416 OT VITA ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3570046

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening