MalfunctionJJT
VITROS CHEMISTRY PRODUCTS CKMB SLIDES
Received Jun 8, 2004 · Event occurred May 17, 2004
Report 1319809-2005-00118 · MDR key 592759
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NACatalog number
8058232
Lot number
4912-0130-5667
Product problems
- Incorrect Or Inadequate Test Results
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED OBSERVING FALSELY LOW CKMB RESULTS USING A QC FLUID. FALSE LOW RESULTS MIGHT LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THER WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.