BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT D-DIMER

    MDR report key: 1740695 · Received June 29, 2010

    Report

    Report Number
    1823260-2010-03908
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE USER STATED THE D-DIMER PERFORMANCE WAS REMAINING ACCEPTABLE WITH D- DIMER REAGENT LOT NUMBER 627070. NO FURTHER EVENTS WERE REPORTED. THE ANALYZER WAS A COBAS INTEGRA 800 (B)(4).

    Description of Event or Problem · 1

    THE USER EXPERIENCED ISSUES WITH LOW QUALITY CONTROLS AND PATIENT RESULTS AFTER CHANGING TO A NEW LOT NUMBER OF D-DIMER REAGENT. THE USER PROVIDED RESULTS FOR TWO PATIENT SAMPLES. FOR SAMPLE 1, THE RESULT AT THIS SITE WAS 0.69 UG/ML WITH LOT NUMBER 621675 AND THE RESULT FROM THE SAME SAMPLE TESTED AT ANOTHER SITE ON (B) (6) 2010 ON AN INTEGRA 400 WAS 0.90 UG/ML. THE USER REPEATED THE SAMPLE WITH LOT NUMBER 627070 AND RECEIVED A RESULT OF 0.80 UG/ML WITH A DATA FLAG. THE RESULT OF 0.69 UG/ML WAS REPORTED TO THE PHYSICIAN AS 0.7 UGFEU/ML. THE USER STATED BOTH RESULTS ARE ABOVE THE EXPECTED VALUE RANGE AND SHE DID NOT PLAN TO SEND A CORRECTED REPORT. SAMPLE 2 WAS FROM A (B) (6) MALE (B) (6). ON (B) (6) 2010 THE INITIAL RESULT WAS 0.56 UG/ML WITH LOT NUMBER 621675 AND WAS REPORTED TO THE PHYSICIAN AS 0.6 UG/ML. THE SAMPLE WAS REPEATED WITH LOT NUMBER 627070 AND GENERATED A RESULT OF 0.69 UG/ML WITH A DATA FLAG. THE USER STATED THERE WAS NO AFFECT TO THE PATIENT AND THEY DO NOT PLAN TO SEND A CORRECTED REPORT AS BOTH ARE ELEVATED AND THE LIS REPORTED 0.6 UG/ML. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 11.5 MM ICM115V4 IMPLANTABLE COLLAMER LENS ON (B) (6)2010 IN THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B) (6)2010 DUE TO INADEQUATE VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. SEE MFR REPORT #2023826-2010-00674 FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINA-QUANT D-DIMER TINA-QUANT D-DIMER TEST SYSTEM GHH ROCHE DIAGNOSTICS NA 62167501

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR NIFEDIPINE CAPS, PATIENT 1| TERAZOSIN HCL, PATIENT 2| KEFLEX,PATIENT 1| ASPIRIN, PATIENT 2| LISINOPRIL, PATIENT 2