COMBUR 6-TEST 50 STR.
Received Aug 20, 2019 · Event occurred Aug 2, 2019
Report 1823260-2019-03045 · MDR key 8911137
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896962257
Lot number
36897602
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
THE CUSTOMER WAS UNABLE TO PROVIDE THE AFFECTED MATERIAL FOR INVESTIGATION. RETENTION LOT OF STRIPS WERE VISUALLY CHECKED AND SHOWED NO ABNORMALITIES AND NO SIGNS OF DISCOLORATION. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER STATED THAT THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS TESTED FOR NITRITE USING COMBUR 6 TEST STRIPS. ALL PATIENTS THAT WERE TESTED HAD POSITIVE NITRITE RESULTS WHEN USING STRIPS FROM ONE VIAL. TESTING WAS REPEATED USING A NEW PACKAGE/VIAL OF TEST STRIPS FROM THE SAME LOT AND ALL NITRITE RESULTS WERE NEGATIVE.