MalfunctionLDM
VITROS IMMUNODIGANOSTIC PRODUCTS TROPONIN I REAGENT PACK
Received Jun 9, 2004 · Event occurred May 8, 2004
Report 9680658-2004-00120 · MDR key 579304
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsModel number
*Catalog number
6801324
Lot number
1100
Product problems
- Incorrect Or Inadequate Test Results
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBSERVED REPEATABLE ELEVATED TROPONIN I RESULTS ON ONE PT'S SAMPLES. A NON-OCD ASSAY GAVE NEGATIVE RESULTS. FALSELY ELEVATED TROPONIN I RESULTS COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.