COMBUR 4
Received Jan 3, 2020 · Event occurred Nov 26, 2019
Report 1823260-2020-00016 · MDR key 9543934
Device
Generic name
Urinary Glucose (nonquantitative) Test System
Manufacturer
Roche DiagnosticsModel number
COMBUR 4Catalog number
11896822191
Lot number
ASKU
Product problems
- Missing Information
- Missing Information
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE VIAL WAS RETURNED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE REPORTER. THE VIAL CONTAINED 32 OUT OF 50 TEST STRIPS AND THE TEST STRIPS SHOW SIGNS OF DISCOLORATION ON THE GLUCOSE, NITRITE, AND PROTEIN TEST PADS. THE VIAL LABEL WAS MISSING THE EXPIRATION DATE AND LOT NUMBER INFORMATION. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED 1 VIAL OF COMBUR 4 TEST STRIPS THAT HAD THE LOT NUMBER AND EXPIRATION DATE INFORMATION MISSING FROM THE VIAL LABEL. THE TEST STRIPS APPEARED TO BE IN USE AS THERE WERE ONLY 30-32 TEST STRIPS OUT OF 50 REMAINING.
Additional Manufacturer Narrative
THE CUSTOMER MATERIAL WAS PROVIDED WITHOUT THE OUTER CARTON WHICH WAS NECESSARY FOR FURTHER EVALUATION. THE INVESTIGATION DETERMINED THAT THIS ISSUE IS NON SYSTEMIC. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.