BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2951005 · Received February 8, 2013

    Report

    Report Number
    3008382007-2013-02512
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 5, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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- 2/20/2013, TEST STRIPS- 2/5/2013.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS CROATIA ON (B)(6) 2013, ALLEGING INACCURATE ERRATIC READINGS ON THEIR VERIO PRO METER. THE PATIENT MENTIONED THAT ON THE MORNING OF (B)(6) 2013, AT 8:10AM, THE PATIENT HAD OBTAINED THE FOLLOWING READINGS : 10.8 MMOL/L 8.2 MMOL/L, AND 8.1 MMOL/L. THE READINGS WERE DONE LESS THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT DENIED BEING TESTED ON ANOTHER DEVICE; HOWEVER, MENTIONED THAT DUE TO THE ALLEGED HIGH READINGS HER PHYSICIAN INCREASED HER DOSAGE OF MEDICATION. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS THAT THE PATIENT HAD BEEN USING WERE EXPIRED. USING EXPIRED TESTING SUPPLIES CAN LEAD TO FALSE BLOOD GLUCOSE READINGS. THIS COMPLAINT WAS INITIALLY RULED OUT DUE TO THE FOLLOWING CONCLUSIONS: AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. DUE TO THE METER READINGS, PHYSICIAN INCREASED HER DOSAGE OF MEDICATION. THERE IS ALSO NO EVIDENCE THAT THE METER MALFUNCTIONED SINCE THE TEST STRIPS THE PATIENT WAS USING WERE EXPIRED. ON (B)(4) 2013, LIFESCAN RECEIVED THE TEST STRIPS INVOLVED WITH THE COMPLAINT. THE ALLEGED INACCURACY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED DURING INVESTIGATIONS. AN "ERROR 4" ISSUE OCCURRED WITH THE RETURNED TEST STRIPS. THIS COMPLAINT IS NOT BEING REPORTED DUE TO THE SECONDARY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54588 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3270810

    Patients

    Seq Age Sex Outcome Treatment
    1