COMBUR 5-TEST HC 10 STR.
Received Nov 25, 2019 · Event occurred Nov 4, 2019
Report 1823260-2019-04175 · MDR key 9370087
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896954176
Lot number
415677-01
Product problems
- Missing Information
- Missing Information
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 41567701 WAS VISUALLY CHECKED. THE RETENTION MATERIAL SHOWS NO ABNORMALITIES. ONE VIAL OF TEST STRIPS WAS RETURNED FOR INVESTIGATION. THE LABEL ON THE TEST STRIP VIAL IS MISSING. TECHNICAL DOCUMENTATION, LOGBOOK, AND PRODUCTION DOCUMENTATION WERE CHECKED AND THERE WERE NO ENTRIES WHICH COULD IMPLY THE ROOT CAUSE OF THIS ERROR PATTERN. AN UNKNOWN TECHNICAL FAILURE OCCURRING DURING MANUFACTURING IS THE ROOT CAUSE OF THE DEFECTIVE VIAL.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A VIAL OF COMBUR 5 TEST STRIPS WHICH DID NOT HAVE THE COMPLETE LABEL AFFIXED TO THE VIAL. THE VIAL LABEL WAS COMPLETELY MISSING, SO THE COLOR COMPARISON SCALE USED FOR INTERPRETING TEST RESULTS WAS MISSING. THE OUTER PACKAGING OF THE VIAL WAS LABELED WITH INFORMATION INCLUDING THE LOT AND EXPIRATION DATE. THE TEST STRIPS WERE NOT USED. THE REPORTER ALSO HAD NO OTHER TEST STRIPS OF THE SAME LOT NUMBER NEARBY.