BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3863862 · Received June 10, 2014

    Report

    Report Number
    2939301-2014-14038
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 2, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    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 VERIO IQ METER INTERMITTENTLY DISPLAYED AN UNKNOWN ERROR MESSAGE THAT INDICATED THE FOLLOWING: ¿FAILURE TO FILL STRIP PLEASE TRY USING NEW STRIPS¿. MEDICAL SURVEILLANCE SENT FOLLOW-UP QUESTIONS; HOWEVER CUSTOMER SERVICE (CS) WAS UNSUCCESSFUL IN REACHING THE PATIENT BY PHONE. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CS REPRESENTATIVE DURING THE PATIENT¿S INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE BEGAN (B)(6) 2014. THE PATIENT TEST THREE TIMES A DAY AND MANAGES HIS DIABETES WITH DIAMICRON (2 TABLETS; 60MG), LANTUS, AND METFORMIN (1 TABLET; 500MG). HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ON (B)(6) 2014, THE PATIENT REPORTEDLY CONTACTED HIS PHYSICIAN BECAUSE HE WAS UNABLE TO OBTAIN A READING WITH THE SUBJECT METER; THE PATIENT WAS LATER ADVISED (BY HIS PHYSICIAN) TO GO TO THE HOSPITAL. PRIOR TO CONTACTING HIS PHYSICIAN, IT IS NOT KNOWN WHAT HIS PREVIOUS BLOOD GLUCOSE READING WAS WITH THE SUBJECT METER, WHEN HE OBTAINED HIS READING, AND WHAT ACTION HE TOOK IN RESPONSE TO HIS RESULT. PER CSR NOTES, WHEN HE ARRIVED AT THE HOSPITAL, THE ATTENDING (HOSPITAL) PHYSICIAN TESTED THE PATIENT WITH BOTH THE HOSPITAL¿S METER AND THE SUBJECT METER. ACCORDING TO THE PATIENT HE OBTAINED IDENTICAL HIGH READINGS ON BOTH METERS (RESULT NOT SPECIFIED) AND WAS SOON AFTER ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN AS TREATMENT BY THE PHYSICIAN. THE PATIENT REPORTEDLY WAS ADMITTED AND HOSPITALIZED FOR SIX DAYS; REASON FOR HOSPITALIZATION IS NOT SPECIFIED. THE PATIENT INDICATED, HE IS SCHEDULED FOR EYE SURGERY ON (B)(6) 2014. DURING TROUBLESHOOTING, THE PATIENT REPORTEDLY WAS UNABLE TO PROVIDE THE TEST STRIP LOT NUMBER BECAUSE HIS VISION WAS REPORTEDLY ¿BAD¿. THE ALLEGED PRODUCT ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE, THE USER CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY A HEALTH CARE PROFESSIONAL FOR SEVERE HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN AND WAS REPORTEDLY HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340777 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R