COMBUR 10

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT NEGATIVE RESULTS FOR 1 PATIENT TESTED WITH THE COMBUR 10 TEST M URINE TEST STRIP ON A COBAS U411 URINE ANALYZER. THE LEUCOCYTES RESULT FROM THE URINE TEST STRIP WAS 500 LEUCOCYTES/L AND CONSIDERED NEGATIVE. THE ERYTHROCYTES RESULT FROM THE URINE TEST STRIP WAS 250 ERY/L AND CONSIDERED NEGATIVE. THE MEASUREMENT WAS REPEATED TWICE USING MANUAL STRIPS. 1ST REPEAT RESULT: THE LEUCOCYTES RESULT WAS 500 LEUCOCYTES/L AND CONSIDERED NEGATIVE. THE ERYTHROCYTES RESULT WAS 10 ERY/L. 2ND REPEAT RESULT: THE LEUCOCYTES RESULT WAS 500 LEUCOCYTES/L AND CONSIDERED NEGATIVE. THE ERYTHROCYTES RESULT WAS 25 ERY/L.

Additional Manufacturer Narrative

THE COMBUR 10 TEST M URINE TEST STRIP EXPIRATION DATE WAS NOT PROVIDED. THE COBAS U411 URINE ANALYZER SERIAL NUMBER WAS (B)(6). THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 74839700 WAS CHECKED BY VISUAL READING WITH 0-NATIVE URINE AND SHOWED POSITIVE. THE ERY SHOWED GREEN SPOTS ON THE COLOR SCALE. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE TEST STRIPS WERE RECEIVED FOR INVESTIGATION WHERE THEY WERE TESTED USING RETENTION MATERIAL LOT NUMBER 74839700 AND THEY WERE: 1) MEASURED ON A COBAS U411 ANALYZER WITH 0-NATIVE-URINE, AN ERYTHROCYTES-DILUTION-SERIES AND A LEUKOCYTES-DILUTION-SERIES. 2) CHECKED BY VISUAL READING WITH 0-NATIVE-URINE, AN ERYTHROCYTES-DILUTION-SERIES AND A LEUKOCYTES-DILUTION-SERIES. THE INVESTIGATION RESULTS WERE ACCEPTABLE AND NO FALSE NEGATIVE RESULTS WERE OBSERVED. THE PROVIDED QC DATA DID NOT POINT TO A POSSIBLE INSTRUMENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.