COBAS U PACK
Received May 14, 2020 · Event occurred Apr 28, 2020
Report 1823260-2020-01226 · MDR key 10058243
Device
Generic name
Urine Test Strip
Manufacturer
Roche DiagnosticsModel number
NACatalog number
06334601001
Lot number
ASKU
Product problems
- False Positive Result
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE REPORTER TRIED REMOVING THE COBAS U PACK MANUALLY, BUT COULD NOT DO IT. THE REPORTER LATER NOTED THAT THEY HAD INSTALLED A DAMAGED COBAS U PACK BY MISTAKE. THE REPORTER LATER WAS ABLE TO REMOVE THIS PACK AND THE ANALYZER WAS WORKING AFTER THIS. THE AFFECTED COBAS U PACK WAS THROWN IN THE TRASH. PHONE NUMBER WAS PROVIDED AS (B)(6). THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT NITRITE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH A COBAS U PACK ON A COBAS U 601 URINE ANALYZER. INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER ALSO INDICATED THERE WAS AN ERROR WITH THE COBAS U PACK. THE REPORTER STATED SHE RAN QUALITY CONTROL MATERIAL AND PATIENT SAMPLES AND ALL RESULTED WITH POSITIVE VALUES FOR NITRITE. THE REPORTER REPEATED THE PATIENT SAMPLES AND CONTROL AND RECEIVED NEGATIVE NITRITE VALUES. THE REPORTER BELIEVES ALL PATIENT SAMPLES AND CONTROL WERE INITIALLY FALSE POSITIVE. THE U 601 ANALYZER SERIAL NUMBER IS (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE.