MalfunctionKHE
HEMAPROMPT FG
Received Mar 11, 2020 · Event occurred Feb 25, 2020
Report 9817722 · MDR key 9817722
Device
Generic name
Reagent, Occult Blood
Manufacturer
Aerscher DiagnosticsModel number
HPFGLot number
159 / 161
Product problems
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
HEMAPROMPT TESTING AREA NOTED TO ALREADY BE TINTED BLUE PRIOR TO SPECIMEN ON AREA. LOT #159, 161. THE REMAINDER FOR LOT #159, 161 REMOVED FROM STOCK. TESTING PERFORMED ON DIFFERENT LOT OF HEMAPROMPT TESTING STRIPS.
Description of Event or Problem
HEMAPROMPT TESTING AREA NOTED TO ALREADY BE TINTED BLUE PRIOR TO SPECIMEN ON AREA. LOT #159, 161. THE REMAINDER FOR LOT #159, 161 REMOVED FROM STOCK. TESTING PERFORMED ON DIFFERENT LOT OF HEMAPROMPT TESTING STRIPS.