BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 3072702 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08724
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE ALLEGED INACCURATE READINGS WERE NOT REPRODUCIBLE. THE TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND. HOWEVER A SECONDARY ISSUE UNRELATED TO THE COMPLAINT WAS FOUND. THE TEST STRIP VIAL HAD ILLEGAL OVERPRINT ON THE LABEL. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT HAS NOT BEEN RETURNED TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS)(B)(4), ALLEGING THAT THE ONETOUCH SELECT METER IS GIVING HIGH READING 40 POINTS HIGHER THAN THE LAB RESULT. THIS COMPLAINT IS CLASSIFIED ACCORDING THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT MANAGES HIS DIABETES WITH PILLS, DIET, AND EXERCISE. THE PATIENT CLAIMED THAT HE HAD A HEART ATTACK AND WAS HOSPITALIZED BECAUSE OF THE ALLEGED INCORRECT METER READINGS. THE PATIENT COULD NOT PROVIDE THE LAB NUMERIC VALUE AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS SET CORRECTLY. THE SAMPLE OF BLOOD WAS TAKEN FROM APPROVED SITE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION FOR A HEART ATTACK AFTER THE ALLEGED INACCURATE HIGH READING ISSUE BEGAN. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174586 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R