OtherJHG
AMINIOSTAT-FLM
Received May 22, 2003 · Event occurred May 21, 2003
Report MW1028529 · MDR key 462617
Device
Generic name
Lab Testing Device
Manufacturer
Irvine ScientificModel number
*Catalog number
D101-006
Lot number
A621013
Product problems
- Incorrect Or Inadequate Test Results
Patient
0 DAY
- Respiratory Distress
- Hospitalization required
Narrative
Description of Event or Problem
TWO DIFFERENT PTS GOT TWO DIFFERENT RESULTS FROM TWO KITS. BOTH DEVELOPED RESPIRATORY PROBLEMS AND HAD TO BE TRANSPORTED.