BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 4123967 · Received September 27, 2014

    Report

    Report Number
    2939301-2014-25677
    Event Type
    Injury
    Date Received
    September 27, 2014
    Report Date
    September 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/02/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/22/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/20/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/20/2014), THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/8/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/9/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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

    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

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH VITA METER IS GIVING INACCURATE HIGH READINGS OVER 600 MG/DL COMPARED TO NORMAL READING/FEELING. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THAT SHE TOOK INSULIN BASED ON A MESSAGE ¿HI, ABOVE 600 MG/DL¿ ON TWO DIFFERENT OCCASIONS, (B)(6) 2014, AND WENT UNCONSCIOUS. SHE REQUIRED MEDICAL INTERVENTION WITH IV FLUID AT THE EMERGENCY ROOM WHERE SHE WAS TESTED ON THE HOSPITAL METER AT ¿0.3 MG/DL.¿ DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS SET CORRECTLY AT THE TIME OF TESTING. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION FOR HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE ALLEGED INACCURATE HIGH RESULTS ON THE LFS METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603829 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3631340

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R