BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2923361 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01081
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K11063731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO LIFESCAN. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (4/2/2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING. THE PRIMARY COULD NOT BE REPRODUCED. UNRELATED TO THE REPORTED ISSUE, THERE WAS AN ERROR 4 ISSUE FOUND WITH THE TEST STRIPS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- (B)(6) 2013, TEST STRIPS- (B)(6) 2013. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THE ONETOUCH VERIO IQ METER GAVE AN INACCURATE READING OF 22.0 MMOL/L COMPARED TO ANOTHER METER READING OF 7.X MMOL/L. ACCORDING TO THE PATIENT, HE TOOK INSULIN BASED ON THE LFS METER READING AND SUBSEQUENTLY HAD A LOW BLOOD GLUCOSE READING OF 3.X MMOL/L. HIS SYMPTOMS AT THE TIME OF CONCERN WERE DIZZY AND SWEATING. THE PATIENT WAS ABLE TO ADMINISTERED SELF TREATMENT WITH FOOD. THE PATIENT FURTHERMORE CLAIMED THE SUBJECT METER IS GIVING 1-2 MMOL/L HIGHER THAN THE OTHER METER. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THE RESULTS WERE PERFORMED WITHIN 30 MINUTES. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7 MMOL/L. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD A LOW BLOOD GLUCOSE READING OF 3.X MMOL/L AND SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED THE LFS METER READING. THE PRODUCT WAS REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31407 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening