COMBUR 5-TEST HC 10 STR.
Received Oct 31, 2018 · Event occurred Oct 10, 2018
Report 1823260-2018-03943 · MDR key 8023144
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896954176
Lot number
32221301
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THE LABEL WAS MISSING FROM THE BOX AND THE VIAL OF THE COMBUR 5 TEST STRIPS. THE CUSTOMER INSPECTED THE REMAINING PRODUCT AND IT WAS "OKAY". THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO TEST STRIPS WERE USED. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 32221301 WAS VISUALLY CHECKED AND THE BOXES HAD THE CORRECT LABEL.
Additional Manufacturer Narrative
ONE TEST STRIP VIAL OF LOT 32221301 WAS RECEIVED FROM THE CUSTOMER AND THE MISSING LABEL WAS CONFIRMED. RETENTION MATERIAL OF LOT 32221301 WAS VISUALLY CHECKED AND THE LABEL WAS FOUND TO BE MISSING ON SEVERAL VIALS. THE LABEL WAS CONFIRMED TO BE PRESENT ON THE BOXES. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED, IT COULD NOT BE EXCLUDED THAT AN UNLABELED VIAL PASSED THROUGH THE PACKAGING PROCESS UNDETECTED.