COMBUR 5-TEST HC 10 STR.
Received Nov 14, 2018 · Event occurred Oct 8, 2018
Report 1823260-2018-04263 · MDR key 8068772
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896954176
Lot number
34760801
Product problems
- Missing Information
- Missing Information
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER STATED THE LABEL ON A COMBUR 5-TEST STRIP VIAL WAS MISSING. THE LABEL CONTAINING THE VISUAL READING COLOR SCALE WAS NEITHER ON THE VIAL OR LOOSE WITHIN THE BOX. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED. THE CUSTOMER'S PRODUCT WAS REQUESTED FOR INVESTIGATION. ONE BOX CONTAINING A TEST STRIP VIAL WAS RECEIVED FOR INVESTIGATION. THE BOX PACKAGING IS LABELED AND SHOWED NO ABNORMALITIES. THE LABEL ON THE TEST STRIP VIAL WAS MISSING. THE VIAL SHOWED SOME SLIGHT SCRATCHES. THE STOCK OF RETENTION SAMPLES WERE VISUALLY CHECKED AND THE BOXES SHOW THE CORRECT PLACED LABEL.