BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2057985 · Received April 14, 2011

    Report

    Report Number
    2939301-2011-03120
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(4) 2011) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH VERIO METER. THE PATIENT MENTIONED THAT SHE NOTICED A DIFFERENCE ON HER VERIO METER COMPARED TO HER ONE TOUCH VITA METER. SHE FEELS THAT THE VERIO CAUSED HER TO TAKE TOO MUCH INSULIN, WHICH CAUSED HER TO DEVELOP HYPOGLYCEMIC SYMPTOMS SEVEN TIMES IN (B)(6) 2011. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER FIRST BEGAN SOMETIME AROUND MID (B)(6). A NORMAL READING FOR THE PATIENT IS BETWEEN 4-8 MMOL/L. ON (B)(6) 2011 AT AROUND 10:30PM, THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 16.0 MMOL/L AND TOOK 30 UNITS OF LANTUS. THE FOLLOWING MORNING AT 8:00AM, SHE OBTAINED A 10 MMOL/L AND TOOK 18 UNITS OF NOVORAPID INSULIN. AT AROUND 12:15PM SHE DEVELOPED SYMPTOMS OF FEELING DIZZY, SHAKY, HEADACHE, SWEATY AND COULD NOT STAND. SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 3.7 MMOL/L AND TOOK 14 UNITS OF INSULIN. THE PATIENT TOOK THE INSULIN, SINCE SHE KNEW SHE WAS GOING TO EAT. SHE THEN SELF-TREATED WITH 6 PIECES OF DEXTRO ENERGY AND ATE AN EXTRA SANDWICH. SYMPTOMS LASTED 15-20 MINUTES. SHE DID NOT RETEST SOON AFTER SELF-TREATMENT. THE PATIENT MENTIONED THAT SINCE SHE HAS STARTED USING THE VERIO IN MID (B)(6), SHE HAD DEVELOPED 7 HYPOS (FROM MID (B)(6) TILL LATE (B)(6)). DUE TO THE HYPOGLYCEMIC SYMPTOMS, THE PATIENT CONTACTED HER PHYSICIAN FOR ASSISTANCE AND WAS ADVISED FROM THE PHYSICIAN TO CONTINUE TO TEST USING THE VITA AND TO CONTINUE TO TAKE THE INSULIN. THE PATIENT'S INSULIN WAS NOT CHANGED DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, SHE 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
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3087179

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R