BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA ENHANCED METER

    MDR report key: 5513122 · Received March 21, 2016

    Report

    Report Number
    2939301-2016-13404
    Event Type
    Injury
    Date Received
    March 21, 2016
    Report Date
    March 12, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    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 TESTING. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS UNDERWENT FURTHER TESTING AND WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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

    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 FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. 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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VITA ENHANCED METER DISPLAYED INACCURATELY ERRATIC RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THAT THE METER STARTED TO READ INACCURATELY ON (B)(6) 2015, WHEN SHE OBTAINED ALLEGED INACCURATELY ERRATIC RESULTS ON THE SUBJECT METER OF "150-190 MG/DL" WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE LFS' PRECISION CRITERIA. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). SHE REPORTED THAT DUE TO THE RESULTS ON THE SUBJECT METER, AROUND (B)(6) 2015, HER NURSE INCREASED HER HUMALOG INSULIN FROM 20 TO 24 UNITS IN THE MORNING AND FROM 20 TO 22 UNITS IN THE EVENING. THE PATIENT CLAIMED THAT DUE TO THE INCREASED INSULIN SHE "SOMETIMES HAD HYPOGLYCEMIA" WITH SYMPTOMS OF TREMBLING, TIREDNESS AND BLURRY VISION WHICH SHE TREATED WITH FRUIT PASTILLES, TOAST AND JAM. SHE REPORTED THAT SOMETIMES HER BLOOD SUGAR LEVELS WERE AS LOW AS "50 MG/DL". SHE DENIED USING ANY OTHER DEVICE TO CHECK HER BLOOD GLUCOSE LEVELS. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT'S TEST STRIPS HAD BEEN STORED CORRECTLY AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE CSR ALSO NOTED THAT THE PATIENT HAD DESCRIBED THE CORRECT TESTING STEPS AND SHE HAD TAKEN BLOOD SAMPLES FROM THE SAME APPROVED SAMPLE SITE. HOWEVER, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE METER AND TEST STRIPS. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATELY ERRATIC READINGS ON THE SUBJECT METER, INCREASED HER MEDICATION BASED ON THE RESULTS AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169973 OT VITA ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3844812

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R