COMBUR-9-TEST
Received Mar 13, 2019 · Event occurred Feb 25, 2019
Report 1823260-2019-01053 · MDR key 8417715
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510046040
Lot number
30953203
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
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE NITRATE RESULTS FROM THE COMBUR-9 TEST STRIPS USED FOR URINE TESTING. THE ANALYZER USED WAS NOT PROVIDED. THE CUSTOMER STATED THE NITRATE RESULTS ARE FALSELY POSITIVE FOR MANY PATIENT SAMPLES. NO SPECIFIC COMPARISONS OR REPEAT RESULTS WERE PROVIDED. THE CUSTOMER ALSO STATED THE DESICCANT STOPPER OF THE STRIP VIAL DOES NOT COMPLETELY CLOSE. IT WAS UNKNOWN IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED FOUR VIALS OF THE SUSPECT PRODUCT FOR INVESTIGATION. ALL OF THE RETURNED TEST STRIPS SHOWED DISCOLORATIONS ON THE NITRITE, PROTEIN, GLUCOSE AND ERYTHROCYTE TEST PADS. THE RETENTION MATERIAL SHOWED NO ABNORMALITIES. THE SUSPECT PRODUCT VIALS COULD NOT BE CHECKED FOR DESICCANT STOPPER TIGHTNESS AS EVERY TEST STRIP VIAL HAD BEEN USED. THE DESICCANT STOPPERS THEMSELVES SHOWED NO DAMAGE. THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED AND A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.