COMBUR-9-TEST
Received Feb 26, 2020 · Event occurred Feb 7, 2020
Report 1823260-2020-00565 · MDR key 9756017
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510046040
Lot number
40392902, 39009003
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). REPORTER OCCUPATION IS PURCHASING DEPARTMENT FOR WHOLESALER. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED THAT NITRITE RESULTS ARE ALWAYS FALSE POSITIVE WHEN TESTING ON 2 SPECIFIC LOT NUMBERS OF COMBUR-9 URINE TEST STRIPS. THE ANALYZER USED WAS NOT PROVIDED. THE LOT NUMBERS IN QUESTION ARE: LOT 40392902 WITH AN EXPIRATION DATE OF 30-NOV-2020. LOT 39009003 WITH AN EXPIRATION DATE OF 30-SEP-2020. NO SPECIFIC COMPARISONS OR REPEAT RESULTS WERE PROVIDED.
Additional Manufacturer Narrative
THE CUSTOMER'S TEST STRIPS (LOT 39009003) WERE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 39009000 AND THE CUSTOMER MATERIAL OF LOT 39009003 WERE VISUALLY CHECKED. THE RETENTION MATERIAL SHOWS NO DISCOLORATIONS OR ABNORMALITIES. THE CUSTOMER MATERIAL SHOW SIGNS OF DISCOLORATIONS ON THE TEST STRIPS. THE INVESTIGATION IS ONGOING. MEDWATCH FIELDS D10 AND H3 HAVE BEEN UPDATED.
Additional Manufacturer Narrative
THE CUSTOMER'S TEST STRIPS (LOT 40392902) WERE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 40392902 AND THE CUSTOMER MATERIAL OF LOT 40392902 WERE VISUALLY CHECKED. THE RETENTION MATERIAL SHOWS NO DISCOLORATIONS OR ABNORMALITIES. THE CUSTOMER MATERIAL SHOW SIGNS OF DISCOLORATIONS ON THE TEST STRIPS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.