COMBUR 10-TEST UX 100T
Received Dec 29, 2020 · Event occurred Dec 9, 2020
Report 1823260-2020-03418 · MDR key 11088934
Device
Generic name
Method, Enzymatic, Glucose (urinary, Non-quantitative)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11544373191
Lot number
ASKU
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD 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, BUT THE CUSTOMER NO LONGER HAS THE TEST STRIPS. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT ERYTHROCYTES RESULT FOR ONE PATIENT SAMPLE TESTED WITH COMBUR 10 UX TEST STRIPS. A SAMPLE FROM THE PATIENT WAS TESTED WITH THE COMBUR 10 UX TEST STRIP AND A VISUAL READ OF THE STRIP DETERMINED THE SAMPLE WAS NEGATIVE FOR ERYTHROCYTES. THE PATIENT WENT TO THE HOSPITAL AND A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED APPROXIMATELY 6 HOURS LATER USING AN UNKNOWN METHOD, RESULTING WITH A 4+ VALUE FOR ERYTHROCYTES. THE PATIENT DID NOT EAT OR DRINK IN BETWEEN THE TWO SAMPLE COLLECTIONS.