BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 3112048 · Received May 14, 2013

    Report

    Report Number
    3008382007-2013-11414
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 ((B)(4) 2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL 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 (07/03/2013)-DEVICE EVALUATION: A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 VERIOIQ METER READ INACCURATE HIGH COMPARED TO ANOTHER DEVICE AND HER FEELINGS/NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT INFORMED THE CSR THAT SHE BEGAN TESTING WITH THE SUBJECT METER APPROXIMATELY 4 MONTHS PRIOR TO CONTACTING LFS. THE PATIENT STATED SHE TESTS HER BLOOD GLUCOSE 3-4 TIMES A DAY AND TAKES A SET DOSE OF HUMULIN AND LANTUS INSULIN TO MANAGE HER DIABETES. BEFORE SHE BEGAN TESTING WITH THE SUBJECT METER, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE READINGS WOULD GENERALLY FALL BETWEEN "7.0 AND 8.0 MMOL/L". DURING THE INITIAL CALL TO LFS, THE PATIENT CLAIMED SHE BEGAN TO OBTAIN INACCURATE HIGH READINGS SINCE SHE STARTED TESTING WITH THE SUBJECT METER. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2013, SHE OBTAINED BLOOD GLUCOSE READINGS OF "26.0 MMOL/L" WITH THE SUBJECT METER AND "4.3 MMOL/L" ON A PHARMACY METER (OT VERIOIQ), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED THAT SHE SELF ADMINISTERED AN INCREASED DOSE OF LANTUS INSULIN IN RESPONSE TO THE ELEVATED READING OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED THAT A FEW MINUTES AFTER ADMINISTERING THE INCREASED DOSE OF INSULIN SHE DEVELOPED "DIFFICULTY WITH HER VISION"; A SYMPTOM SHE ASSOCIATED WITH A LOW BLOOD GLUCOSE. THE PATIENT STATED SHE WENT TO THE HOSPITAL IN RESPONSE TO THE SYMPTOMS AND REPORTED SHE WAS TREATED WITH A "SUGARY LIQUID" BY AN HCP DURING THE HOSPITAL VISIT. THE PATIENT STATED THAT HER BLOOD GLUCOSE REGISTERED "3.1 MMOL/L (56 MG/DL)" WHEN TESTED WITH AN ER/HOSPITAL METER AT THE TIME OF HER ARRIVAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212739 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3365799

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R