MalfunctionMSW
IMMULITE THYROGLOBULIN KIT
Received Dec 15, 2000 · Event occurred Nov 14, 2000
Report 2017183-2000-00001 · MDR key 309279
Device
Generic name
In-vitro Diagnostic Test Kit
Manufacturer
Diagnostic Products CorporationModel number
NACatalog number
LKTY1
Lot number
216
Product problems
- High Test Results
Patient
*
- Therapy/non-surgical treatment, unncessary
Narrative
Description of Event or Problem
DISTRIBUTOR REPORTED THAT A CUSTOMER REPORTED OBTAINING SPURIOUSLY HIGH RESULTS WITH THIS KIT. SUBSEQUENTLY, THE PT WAS TREATED, ALTHOUGH LATER INVESTIGATION DETERMINED THAT THIS TREATMENT WAS NOT NECESSARY. TREATMENT WAS NOT A SERIOUS INJURY, HOWEVER, IT COULD POSSIBLY HAVE BEEN UNDER DIFFERENT CIRCUMSTANCES.
Remedial action
- Relabeling