COMBUR-9-TEST 50STR.
Received Dec 12, 2019 · Event occurred Nov 18, 2019
Report 1823260-2019-04397 · MDR key 9459654
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510038191
Lot number
380547-02
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 CUSTOMER RETURNED THE TEST STRIPS. THE RETENTION MATERIAL OF LOT 38054700 AND THE CUSTOMER MATERIAL OF LOT 38054702 WERE VISUALLY CHECKED. THE CUSTOMER'S MATERIAL WAS ALSO TESTED FOR TIGHTNESS. THE RETENTION MATERIAL SHOWED NO DISCOLORATIONS OR ABNORMALITIES. THE CUSTOMER'S TEST STRIPS SHOWED DISCOLORATIONS ON THE NITRITE, PROTEIN, KETONE, UROBILINOGEN AND BILIRUBIN TEST PARAMETERS. THERE WAS AN ISSUE WITH THE TIGHTNESS OF THE STOPPER ON THE CUSTOMER'S TEST STRIP VIAL. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELDS D10 AND H3 HAVE BEEN UPDATED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). THE TEST STRIPS IN QUESTION HAD BEEN STORED IN THE BATHROOM. THE REPORTER STATED THERE WAS SOME SLIGHT PINK DISCOLORATION OF THE NITRITE PARAMETER ON THE UNUSED REMAINING TEST STRIPS. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR 7 PATIENTS TESTED WITHIN A 2 WEEK PERIOD USING COMBUR 9 URINE TEST STRIPS. FOR 2 OF THE 7 PATIENTS, REPEAT TESTING WAS PERFORMED USING A NEW BATCH OF COMBUR 9 TEST STRIPS AND THE RESULTS WERE NEGATIVE. NONE OF THE PATIENTS WERE TREATED BASED ON THE POSITIVE NITRITE RESULTS.