COMBUR 10 UX 100
Received Jul 11, 2019 · Event occurred Jun 13, 2019
Report 1823260-2019-02513 · MDR key 8779987
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11544373049
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THAT THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR NITRITES USING COMBUR 10 UX TEST STRIPS ON URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED WITH A POSITIVE NITRITE RESULT. THE SAMPLE WAS REPEATED THREE TIMES, EACH TIME RESULTING WITH A NEGATIVE NITRITE RESULT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT.
Additional Manufacturer Narrative
THE CUSTOMER¿S METER AND STRIPS WERE REQUESTED FOR INVESTIGATION, BUT THE CUSTOMER COULD NOT PROVIDE THEM. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.