BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4141474 · Received October 4, 2014

    Report

    Report Number
    2939301-2014-26412
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    October 2, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/25/2015 DEVICE EVALUATION.THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 1/13/2015 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/26/2015 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

    CORRECTION TO INCIDENT DESCRIPTION: ON (B)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH IN COMPARISON TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT HE HAD BEEN OBTAINING ¿HIGHER THAN NORMAL READINGS¿ FOR TEN DAYS PRIOR TO CONTACTING LIFESCAN. THE PATIENT DETAILED THAT HE MANAGES HIS DIABETES BY SELF-ADJUSTING HIS HUMALOG INSULIN DOSES AND REPORTED THAT ON (B)(6) 2014, IN RESPONSE TO THE ALLEGEDLY HIGH RESULTS, HE INCREASED HIS HUMALOG DOSE FROM 18 UNITS TO 20 UNITS DURING THE DAY AND 24 UNITS BEFORE HIS EVENING MEAL. THE PATIENT REPORTED THAT AT AROUND 12:00, MIDNIGHT, ON (B)(6) 2014, AFTER THE ALLEGEDLY HIGH RESULTS, HE DEVELOPED SYMPTOMS OF ¿WEAKNESS, FOGGY THINKING AND SAW SPOTS BEFORE HIS EYES¿ WHICH HE ASSOCIATED WITH BEING IN A ¿HYPOGLYCEMIC STATE¿. AT THE TIME OF THE SYMPTOMS HE TESTED HIS BLOOD GLUCOSE AND GOT A RESULT OF ¿10.6MMOL/L¿ ON THE SUBJECT METER, AT 12:00, MIDNIGHT, AND THEN A RESULT OF ¿2.6MMOL/L¿ ON A BG STAR DEVICE, FOUR MINUTES LATER AT 12:04AM ON (B)(6) 2014. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT CLAIMED THAT HE SELF-TREATED WITH GLUCOSE, BUT DID NOT SPECIFY WHEN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT HAD BEEN USING THE CORRECT TESTING STEPS AND THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE PRODUCT ISSUE CAUSED AND/OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENTS REPORTED SIGNS AND SYMPTOMS DO NOT MEET LIFESCAN¿S CRITERIA FOR SEVERE HYPOGLYCEMIA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FROM A HEALTHCARE PROFESSIONAL OR ANY ASSISTANCE FOR TREATMENT FROM ANOTHER PERSON. 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
    621764 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR