BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5096319 · Received September 23, 2015

    Report

    Report Number
    2027969-2015-00692
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    May 27, 2014
    Report Date
    June 15, 2018
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. THERE IS NO INFORMATION AVAILABLE TO SUGGEST A MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S COAGULATION STATUS WAS UNKNOWN AT THE TIME OF ALLEGED EVENT. BASED ON THE INABILITY TO RULE OUT THE POSSIBILITY THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE "PERSONAL INJURY" ALLEGATION, THIS EVENT IS CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, A DEVICE DEFICIENCY CANNOT BE SUBSTANTIATED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH FORM WILL BE COMPLETED AND SUBMITTED.

    Description of Event or Problem · 1

    THIS EVENT WAS IDENTIFIED AS PART OF AN EVALUATION IN WHICH INSURANCE CLAIMS/FILED SUITS COMMUNICATED TO ALERE LEGAL HAD NOT BEEN FORWARDED TO ALERE (B)(4) FOR INVESTIGATION. THERE IS LIMITED INFORMATION AVAILABLE REGARDING THE EVENT AND DUE TO THE TIME GAP BETWEEN WHEN THE COMPLAINT WAS FIRST REPORTED TO WHEN ASD WAS NOTIFIED, ADDITIONAL INFORMATION IS NOT AVAILABLE. COMPLAINANT ALLEGED "PERSONAL INJURY IN CONNECTION WITH USE OF THE INRATIO2 METER." THERE WERE NO INR RESULTS, EVENT DESCRIPTION OR EVENT DATE REPORTED. HISTORICAL INFORMATION RECEIVED FROM ALERE HOME MONITORING, INC. (AHM). THE PATIENT DID NOT REPORT ANY RESULT ISSUES OR INJURY EVENTS TO AHM BETWEEN (B)(6) 2013 AND (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM AHM SERVICES ON (B)(6) 2014. THERE WAS NO REASON PROVIDED AS TO WHY THE SERVICE WAS STOPPED. THERE IS NO INFORMATION AVAILABLE TO SUGGEST A MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S COAGULATION STATUS WAS UNKNOWN AT THE TIME OF ALLEGED EVENT. BASED ON THE INABILITY TO RULE OUT THE POSSIBILITY THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE "PERSONAL INJURY" ALLEGATION, THIS EVENT IS CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, A DEVICE DEFICIENCY CANNOT BE SUBSTANTIATED.

    Description of Event or Problem · 1

    INITIAL MDR:THIS EVENT WAS IDENTIFIED AS PART OF AN EVALUATION IN WHICH INSURANCE CLAIMS/FILED SUITS COMMUNICATED TO ALERE LEGAL HAD NOT BEEN FORWARDED TO ALERE (B)(4) FOR INVESTIGATION. THERE IS LIMITED INFORMATION AVAILABLE REGARDING THE EVENT AND DUE TO THE TIME GAP BETWEEN WHEN THE COMPLAINT WAS FIRST REPORTED TO WHEN (B)(4) WAS NOTIFIED, ADDITIONAL INFORMATION IS NOT AVAILABLE. COMPLAINANT ALLEGED "PERSONAL INJURY IN CONNECTION WITH USE OF THE INRATIO2 METER." THERE WERE NO INR RESULTS, EVENT DESCRIPTION OR EVENT DATE REPORTED. HISTORICAL INFORMATION RECEIVED FROM ALERE (B)(4). ((B)(4)). THE PATIENT DID NOT REPORT ANY RESULT ISSUES OR INJURY EVENTS TO (B)(4) BETWEEN (B)(6) 2013 AND (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM (B)(4)SERVICES ON (B)(6) 2014. THERE WAS NO REASON PROVIDED AS TO WHY THE SERVICE WAS STOPPED. THERE IS NO INFORMATION AVAILABLE TO SUGGEST A MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S COAGULATION STATUS WAS UNKNOWN AT THE TIME OF ALLEGED EVENT. BASED ON THE INABILITY TO RULE OUT THE POSSIBILITY THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE "PERSONAL INJURY" ALLEGATION, THIS EVENT IS CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, A DEVICE DEFICIENCY CANNOT BE SUBSTANTIATED. FOLLOW-UP #1 MDR: ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: HISTORICAL INRATIO INR RESULTS: (B)(6) 2014: 1.7. (B)(6) 2014: 2.0. (B)(6) 2014: 1.9. THERAPEUTIC RANGE: 2.3 - 3.7. WHEN INRATIO INR READING WAS LOW, THE PATIENT WOULD TAKE A DOUBLE DOSE OF COUMADIN. THE PATIENT HAS PRE-EXISTING MEDICAL CONDITIONS BUT NONE SPECIFIED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 AND WAS ON ANTIBIOTICS AT THE TIME OF HER HOSPITALIZATION. THERE WAS NO DIAGNOSIS PROVIDED, NO INRATIO INR RESULTS AT TIME OF HOSPITALIZATION OR LABORATORY INR RESULTS, BUT INDICATED IN THE BELOW STATEMENT "EXTREME BLOOD LOSS". IN (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT HAS BEEN TREATING WITH A RHEUMATOLOGIST DUE TO SEVERE JOINT PAINT THAT HAS DEVELOPED SINCE THE (B)(6) 2014 HOSPITALIZATION. REPORTEDLY, THE PATIENT'S ABILITY TO WALK DIMINISHED AT THE TIME OF THE HOSPITALIZATION AND SHE HAD TO RE-LEARN HOW TO WALK. "THE RHEUMATOLOGIST BELIEVES HER CURRENT CONDITION IS CORRELATED TO THE EXTREME BLOOD LOSS THAT SHE EXPERIENCED IN (B)(6) 2014." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629228 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R INRATIO MONITOR SN: (B)(4).