BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3063601 · Received April 17, 2013

    Report

    Report Number
    3008382007-2013-08152
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 28, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (6/15/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 4/24/2013 AND 6/3/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 (5/20/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 4/25/2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. HOWEVER, IT WAS NOTED THE TEST STRIP VIAL LABEL WAS TORN, MAKING THE CRITICAL INFORMATION UNREADABLE. 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.

    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 INACCURATELY HIGH COMPARED TO HER FEELINGS AND ANOTHER DEVICE. 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 REPORTED THAT ON (B)(6) 2013 AT APPROXIMATELY 9:30 AM SHE BEGAN TO FEEL SWEATY AND SHAKY; SYMPTOMS SHE ASSOCIATED WITH A LOW BLOOD GLUCOSE. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE IMMEDIATELY TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A READING OF "16.6 MMOL/L (299 MG/DL)" WHICH SHE FELT WAS INACCURATELY HIGH. THE PATIENT REPORTED THAT SHE THEN TESTED WITH HER AVIVA NANO METER AND OBTAINED A READING OF "3.7 MMOL/L (67 MG/DL)". BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30% AND/OR 30 MG/DL. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE TREATED HERSELF WITH FOOD AND/OR DRINK. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT STATED SHE HAD LAST TESTED WITH THE SUBJECT METER ON THE EVENING OF (B)(6) 2013 PRIOR TO GOING TO BED. THE PATIENT DID NOT RECALL THE SPECIFIC RESULT OBTAINED BUT BELIEVES IT WAS IN THE "9 MMOL/L RANGE" AND MENTIONED THE RESULT OBTAINED WAS NOT UNUSUAL. THE PATIENT MANAGES HER DIABETES BY TAKING A SET DOSE OF LANTUS IN THE MORNING AND AT BEDTIME AND TAKING HUMALOG INSULIN WITH HER MEALS (DOSE ADJUSTED BASED ON SLIDING SCALE). THE PATIENT CLAIMED SHE TOOK HER USUAL DOSE OF LANTUS INSULIN (26 UNITS) AFTER SHE HAD TESTED ON THE EVENING OF (B)(6) 2013. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND WAS USING TEST STRIPS THAT WERE WITHIN THEIR EXPIRATION/DISCARD DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS ALREADY SYMPTOMATIC WHEN SHE OBTAINED THE ALLEGED INACCURATE HIGH RESULT WITH THE SUBJECT METER. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164042 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3423380

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR