BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2248366 · Received September 8, 2011

    Report

    Report Number
    2027969-2011-01933
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS ON LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." PT IS ALSO ON SEVERAL OTHER MEDICATIONS. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." CUSTOMER SOMETIMES MILKS FINGER. PER PRODUCT USER GUIDE - PRECAUTIONS AND WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE. "SQUEEZING THE FINGER STICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE IN ACCURATE RESULTS. QC ERRORS ARE DESIGNED TO BE GENERATED IF THE STRIP HAS BEEN EXPOSED TO ADVERSE ENVIRONMENTAL CONDITION. THERE IS NO INFO IN THE COMPLAINT TO INDICATE STRIP EXPOSURE. THESE ERRORS ALSO ARISE IF THERE IS A SAMPLING OR TECHNIQUE PROBLEM. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF CORRECTIVE ACTION IS WARRANTED. NES ERROR OCCURS WHEN THERE IS NOT ENOUGH SAMPLE APPLIED TO THE TEST STRIPS TO FILL THE TEST AREA, AND/OR STRIP CHANNEL IS BLOCKED. ONE HUNDRED THIRTEEN TOTAL COMPLAINTS HAVE BEEN REPORTED FOR LOT #253024 YIELDING A COMPLAINT RATE OF 0.188%. THIS REACHES THE ACTION THRESHOLD OF 0.1%. BRICK LOT NUMBER #246550 HAS STRIP CODE TS4XB; MATERIAL WAS SPLIT INTO THREE DIFFERENT LOTS: LOT #253024 INTO 12 PACKS (SMALLER LOT). LOT #243394 INTO 12 PACKS (SMALLER LOT), LOT #253028 INTO 48 PACKS (LARGER LOT). THEREFORE, 217 TOTAL COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBER'S 253024, 243394, 253028 YIELDING A COMPLAINT RATE OF 0.065%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF 0.1%, CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE; (B)(6) 2011, INRATIO: QC1+2; RE-TEST: QC1+2; RE-TEST: NES. PT SELF TESTER WAS UNABLE TO GET A RESULT, SO NURSE DID A VENOUS DRAW AND RESULTS CAME BACK AT 18.X. PT WAS IMMEDIATELY ADMITTED TO THE HOSPITAL FROM (B)(6) 2011-(B)(6) 2011. PT'S SON STATES THAT THERE WAS A SMALL BRUISE ON HER LEG BECAUSE SHE HAD PUMPED INTO SOMETHING. PT HAD FALLEN AND BROKE HER BACK SO SHE WAS IN A REHAB/NURSING HOME FROM (B)(6) 2011-(B)(6) 2011. WHILE IN THE NURSING HOME, SHE WAS GIVEN LONENOX INJECTIONS. SON DOES NOT REMEMBER WHEN THE INJECTIONS STROPPED, HOWEVER, HE KNOWS THAT SHE WAS NO LONGER TAKING LOVENOX AFTER LEAVING THE NURSING HOME. PT SOMETIME MILKS THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 253024

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization