BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2179021 · Received July 26, 2011

    Report

    Report Number
    3008382007-2011-00072
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K093745. 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) 2011) - DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT WAS TESTED AND NO FAULTS WERE FOUND. THE RETAINS WERE ALSO TESTED AND NO FAULTS WERE FOUND. THE TEST STRIPS WERE ALSO TESTED AND FOUND TO HAVE FAILED FOR CONTROL SOLUTION HIGH. 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

    THE LAY USER /PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH VERIO METER COMPARED TO HIS ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT ON (B)(6) 2011 IN THE AFTERNOON, HE HAD COMPARED HIS VERIO METER TO HIS ONE TOUCH ULTRA 2 METER AND NOTICED A DIFFERENCE BETWEEN THE 2 METERS. ON BOTH DAYS HE OBTAINED THE SAME READINGS ON BOTH OF HIS METERS AND DEVELOPED THE SYMPTOMS ON BOTH DAYS. HE OBTAINED A 7.2 MMOL/L ON HIS VERIO METER AND A 5.3 MMOL/L ON HIS ONE TOUCH ULTRA 2 METER ON THE AFTERNOON OF (B)(6) 2011. THE PATIENT TOOK HIS 16 UNITS OF NOVORAPID INSULIN AND ATE LUNCH. AT AN UNSPECIFIED TIME LATER HE HAD DEVELOPED SYMPTOMS OF FEELING DIZZY AND SWEATY. PATIENT THEN TESTED ON HIS ULTRA 2 METER AND OBTAINED A RESULT OF 3.4 MMOL/L AND SELF-TREATED BY EATING AN EXTRA SANDWICH WITH MARMALADE AND 2X DEXTRO ENERGY TABLETS. HE FELT BETTER 15-20 MINUTES LATER. HE DID NOT ATTEMPT TO TEST HIS BLOOD GLUCOSE READING ON HIS VERIO METER AT THE TIME OF SYMPTOMS. HE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. A NORMAL READING FOR THE PATIENT IS BETWEEN 6.0-7.2 MMOL/L. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT AND A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN AND WAS IN GOOD CONDITION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED DUE TO THE HIGH READING, HE TOOK INSULIN AND AT AN UNSPECIFIED TIME LATER DEVELOPED SYMPTOMS AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3167983

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R