BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 5200193 · Received November 4, 2015

    Report

    Report Number
    2939301-2015-47339
    Event Type
    Injury
    Date Received
    November 4, 2015
    Report Date
    November 3, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE RETAIN TEST STRIPS PASSED TESTING. 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:THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. 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) 2015, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY OCCURRED ON AN UNSPECIFIED TIME AND DATE 2 WEEKS PRIOR TO THE ALERT DATE OF (B)(6) 2015. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF 151, 126 AND 163MG/DL WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES BY SELF-ADJUSTING THEIR INSULIN DOSAGE AND IT IS NOT KNOWN WHETHER THEY MADE ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED PRODUCT ISSUE. DURING THE INITIAL CALL WITH THE CSR THE PATIENT REPORTED DEVELOPING SYMPTOMS OF DIZZY AND SWEATY 2 WEEKS AFTER THE ALLEGED INACCURACY OCCURRED. IN RESPONSE TO THESE SYMPTOMS THE PATIENT SELF-TREATED BY CONSUMING MORE FOOD AND/OR DRINK AT 7:30 ON (B)(6) 2015. NO MEDICAL ATTENTION WAS REQUIRED AS A RESULT OF THE ALLEGED PRODUCT ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE PATIENT铠METER WAS REPLACED AND REQUESTED FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY OBTAINED AN INACCURATELY HIGH READING ON THE SUBJECT METER WHICH LED TO THEM DEVELOPING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732521 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3803420

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening