BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2340446 · Received November 17, 2011

    Report

    Report Number
    3008382007-2011-00814
    Event Type
    Injury
    Date Received
    November 17, 2011
    Report Date
    November 16, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (12/09/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/1/2011 AND 12/7/2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. HOWEVER, IT WAS NOTED THAT THE QUANTITY OF TEST STRIPS IN THE VIAL EXCEEDED THE LABELED AMOUNT. 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

    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 LIFESCAN (LFS) (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE READINGS ON HIS VERIO PRO METER COMPARED TO HIS ACCUCHECK METER. THE PATIENT MENTIONED THAT HE HAD OBTAINED A RESULT OF 70 MG/DL WITH HIS ACCUCHECK METER AND A 118 MG/DL ON HIS VERIO PRO METER. DUE THE ALLEGED READING ON HIS VERIO PRO METER, THE PATIENT ADJUSTED HIS INSULIN. AT AN UNSPECIFIED TIME AFTER TESTING HE DEVELOPED SYMPTOMS OF "HYPOGLYCEMIA". THE PATIENT TESTED ON ANOTHER DEVICE AND OBTAINED A RESULT OF 40 MG/DL AND SELF-TREATED WITH FOOD / DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. WHILE TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) HAD THE PATIENT RUN A QUALITY CONTROL TEST AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. THE PRODUCT WAS REPLACED. AT THIS TIME THE COMPLAINT IS BEING REPORTED SINCE PATIENT ADJUSTED HIS INSULIN BASED ON THE VERIO PRO METER AND AT AN UNSPECIFIED TIME LATER DEVELOPED SYMPTOMS AND HAD TO SELF-TREAT WITH FOOD & DRINK FOR A BLOOD GLUCOSE READING OF 40 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3164660

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R