BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4844434 · Received June 15, 2015

    Report

    Report Number
    2027969-2015-00406
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE PRODUCTS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED MONITORS REVEALED NO EVIDENCE OF CONTAMINATION OR DAMAGE. THERMOMETER TESTING OF BOTH MONITORS MET SPECIFICATION. A REVIEW OF THE MONITOR MEMORIES COULD NOT DETERMINE IF EITHER MONITOR WAS USED TO OBTAIN THE CUSTOMER'S REPORTED RESULT. BECAUSE THE SPECIFIC MONITOR COULD NOT BE VERIFIED WITH THE COMPLAINT, IN HOUSE DONOR TESTING WAS NOT PERFORMED ON THE RETURNED MONITORS. SHOULD ADDITIONAL CASE INFORMATION BE PROVIDED IN THE FUTURE, FURTHER INVESTIGATION WITH THE APPROPRIATE MONITOR WILL BE PURSUED. A REVIEW OF IN-HOUSE TESTING OF LOT 357496 WAS PERFORMED. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. FURTHER INVESTIGATION WAS PERFORMED UNDER CAPA-14-005.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PT/INR TEST STRIPS LOT # 367327A REFERENCED IS BEING REPORTED UNDER A SEPARATE MANUFACTURER REPORT NUMBER 2027969-2015-00407. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN QUESTIONING WHY THEY HAD NOT RECEIVED THE MEDICAL DEVICE CORRECTION NOTIFICATION THAT THEY HAD FOUND ON THE ALERE WEBSITE, WHILE REVIEWING THE RETURN POLICY. THE CUSTOMER ALLEGED VARIANCES BETWEEN MULTIPLE INRATIO INR RESULTS AND LABORATORY INR RESULTS ON MULTIPLE PATIENTS WITH SOME PATIENTS ADMITTED TO THE HOSPITAL. THE SPECIFIC DATES AND RESULTS WERE NOT AVAILABLE. THERE WAS ONLY ONE (1) PATIENT RESULT PROVIDED; HOWEVER, THE DATE WAS UNKNOWN. ADDITIONALLY, THE SPECIFIC LOT NUMBER AND MONITOR SERIAL NUMBER COULD NOT BE PROVIDED. THE CUSTOMER COULD NOT VERIFY WHICH OF THESE LOT NUMBERS (357496 OR 367327A) HAD THE VARIANCE. RESULTS ARE AS FOLLOWS: DATE: UNKNOWN, INRATIO INR: 3.1, LABORATORY INR: 12.6, THERAPEUTIC RANGE: UNKNOWN. THE PATIENT WAS HOSPITALIZED AND OUTCOME/TREATMENT COULD NOT BE PROVIDED BY THE CUSTOMER. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387761 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 357496

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INRATIO PT/INR TEST STRIPS LOT # 367327A| INRATIO MONITOR SN (B)(4)