BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2902089 · Received January 8, 2013

    Report

    Report Number
    3008382007-2013-00272
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS BEING REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (3/19/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ON (B)(6) 2013 ALLEGING INACCURATE HIGH READINGS. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT HIS ONE TOUCH VERIO IQ METER WAS DISPLAYING HIGHER READINGS THAN HIS FREESTYLE LITE METER AND ANOTHER BRAND METER. ACCORDING TO THE PATIENT THERE WAS ABOUT A 5 MMOL/L DIFFERENCE BETWEEN THE READINGS. THE PATIENT MENTIONED THAT ON (B)(6) 2013 AT 10:00 PM, THE PATIENT OBTAINED A RESULT OF 9.9 MMOL/L AND TOOK 3 UNITS OF NOVORAPID INSULIN WHEN HE WOULD NORMALLY ONLY TAKE LEVEMIR. HE TOOK THE 3 UNITS TO LOWER HIS BLOOD GLUCOSE AND TOOK THE NOVORAPID INSULIN ON HIS OWN AND NOT BASED ON HIS PHYSICIAN'S RECOMMENDATION. THE PATIENT DID NOT EAT ANYTHING AFTER OBTAINING THE 9.9 MMOL/L READING. HE WOKE UP AT 1:00 AM ON (B)(6) 2013 WITH SYMPTOMS OF FEELING SHAKY, LIGHT HEADED AND "FEELING OF SURREALINESS". HE TESTED HIS BLOOD GLUCOSE ON HIS VERIO IQ AND OBTAINED A 1.8 MMOL/L. HE THEN SELF-TREATED WITH PIE AND CLAIMS THAT HIS SYMPTOMS LASTED FOR APPROXIMATELY 15 MINUTES. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THE NEXT READING HE OBTAINED WAS AT 7.30 AM WITH A RESULT OF 6.3 MMOL/L ON HIS VERIO IQ METER. CUSTOMER SERVICE HAD THE PATIENT RUN A QUALITY CONTROL TEST AND THE TEST STRIPS PASSED USING CONTROL SOLUTION. PATIENT ALSO DID A COMPARISON ON HIS VERIO IQ METER TO THE FREESTYLE LITE METER AND OBTAINED A 4.7 MMOL/L ON HIS LFS METER AND A 4.1 MMOL/L ON THE FREESTYLE LITE METER. PATIENT MENTIONED THAT READINGS OVER 18 MMOL/L OR BELOW 3 MMOL/L ARE READINGS THAT HE WOULD WORRY ABOUT. HE TESTS APPROXIMATELY 8X A DAY. THE PATIENT HAS HAD THE SUBJECT METER FOR APPROXIMATELY 2 WEEKS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READING, HE TOOK INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8652 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3362937

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R