BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALERE HOME INR MONITOR

    MDR report key: 4360709 · Received December 16, 2014

    Report

    Report Number
    MW5039730
    Event Type
    Death
    Date Received
    December 16, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 16, 2014
    Manufacturer
    ALERE
    Product Code
    GJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME INR MONITOR REGISTERED 2.1, PATIENT DEVELOPED BRUISING, HEADACHE, DIED IN BED, AUTOPSY SHOWED LARGE SUBDURAL HEMATOMA. THE INR MANUFACTURER ISSUED RECALL IMMEDIATELY AFTER. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: CLOSELY MONITOR ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823447 ALERE HOME INR MONITOR INR MONITOR GJS ALERE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death INSTILL 2 SPRAYS IN EACH NOSTRIL, ONCE DAILY| FLUNISOLIDE 25MCG/ACT (0.025%) NASAL SOLUTION,| VITAMIN D 2000 UNIT ORAL CAPSULE| AS DIRECTED| ONE TWICE A DAY, CHEWABLE| EPIPEN 2-PAK 0.3MG/0.3ML DEVI, USE AS DIRECTED| TAKE 2 TABS EVERY 4-6 HOURS AS NEEDED FOR MIGRAINE| ONE 325MG TABLET DAILY| SEQOQUEL 50MG, ORAL TABLET (QUETIAPINE FUMARATE),| DEPAKOTE 250MG ORAL TABLET DELYAED RELEASE,| MULTI-DAY VITAMINS, ORAL TABLET, TAKE TAB TWICE,| FISH OIL 000 MG ORAL CAPSULE, TAKE CAP DAILY| EVERY 6 HOURS AS NEEDED.| HYDROMORPHONE HCL - 4MG ORAL TABLET, TAKE TABLET,| FERROUS SULFATE 325 (65 FE) MG, ORAL TABLET,| 6 HOURS AS NEEDED.| DIAZEPAM 5MG, ORAL TABLET, TAKE TABLET EVERY,| MORE AS TOLERATED| (DIVALPROEX SODIUM) TWO TABLETS AT NIGHT, ADDING,| EVERY 4-6 HOURS PRN PAIN| VENLAFAXINE HCL - 75MG ORAL TABLET, ONE A DAY| WARFARIN SODIUM 5 MG ORAL TABLET,| (COUMADIN 5MG ORAL TABLET) COUMADIN CLINIC OR,| ONE TWICE A DAY.| TRAMADOL HCL - 50MG ORAL TABLET, TAKE 2 TABLETS,| ONE PILL TWICE A DAY| SEROQUEL 200MG, ORAL TABLET (QUETIAPINE FUMARATE),| WEEK AS DIRECTED,| WEEKLY, APPLY PATCH TRANSDERMALLY, TWICE A,| OXYTROL 3.9 MG/24HR TRANSDERMAL PATCH TWICE,| A DAY| LEVOXYL 50 MCG, ORAL TABLET, TAKE TABLET DAILY| EVERY 8 HOURS AS NEEDED.| CYCLOBENZAPRINE HCL - 0MG ORAL TABLET, TAKE TAB,| CALCIUM 500/D 500-200 MG, UNIT ORAL TABLET,| BUTALBITAL-APAP-CAFFEINE 50-325-40 MG ORAL TABLET,| TAKE PRN BLADDER PAIN| WELLBUTRIN 00 MG, ORAL TABLET (BUPROPION HCL),| AZO STANDARD, MAXIMUM STRENGTH 97.5 MG ORAL TAB,