MalfunctionLGP
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY
Received Jan 19, 1998 · Event occurred Nov 14, 1997
Report 1025506-1998-00001 · MDR key 145242
Device
Generic name
Troponin-i
Manufacturer
Dade Intl., Inc.Model number
*Catalog number
B5700-64
Lot number
KXTN-670
Patient
UNKNOWN
Narrative
Description of Event or Problem
CUSTOMER CALLED INTO STRATUS TECHNICAL SERVICES REQUESTING THAT CO TEST A PT SAMPLE FOR THEM. THEY INDICATED THAT THEY HAD A PT SAMPLE WITH A TROPONIN-I RESULT OF <0.35 NG/ML (NEGATIVE). THEY SENT THE SAMPLE TO A SISTER HOSPITAL FOR TESTING AND THE RESULT WAS POSITIVE. NO PT INFO WAS GIVEN.