COMBUR 5-TEST HC 10 STR.
Received Jun 26, 2019 · Event occurred Jun 6, 2019
Report 1823260-2019-02327 · MDR key 8735842
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896954176
Lot number
38308901
Product problems
- Missing Information
- Missing Information
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD B1 WAS UPDATED.
Additional Manufacturer Narrative
THE CUSTOMER'S MATERIALS WERE RETURNED. ONE VIAL OF STRIP LOT 38308901 "COMBUR 5-TEST HC 10 STR.", CONTAINING 10 OF 10 TEST STRIPS WAS RETURNED. INVESTIGATION: THE CUSTOMER MATERIAL OF LOT 38308901 AND THE RETENTION MATERIAL OF LOT 38308901 WERE BOTH VISUALLY CHECKED. RESULTS: THE RETENTION MATERIAL SHOWED NO MISSING LABELS ON THE CARDBOARD-BOX AND NO MISSING LABEL ON THE TEST STRIP VIAL. THE LABEL ON THE TEST STRIP VIAL OF THE CUSTOMER MATERIAL IS MISSING. THE RETENTION MATERIAL VISUAL INSPECTION WAS ACCEPTABLE.
Description of Event or Problem
THE INITIAL REPORTER STATED THAT THE LABEL CONTAINING THE RESULT INTERPRETATION COLOR SCALE, LOT NUMBER, AND EXPIRATION DATE WAS MISSING FROM ONE VIAL OF COMBUR 5 TEST STRIPS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.
Additional Manufacturer Narrative
THE MANUFACTURING DOCUMENTS AND THE PACKAGING LOGBOOK SHOWED NO ABNORMALITIES. EVALUATION METHOD, RESULT, AND CONCLUSION CODES HAVE BEEN UPDATED.