DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL
Received Jul 24, 2017 · Event occurred Jul 6, 2017
Report 2250033-2017-00001 · MDR key 6738933
Device
Generic name
Plasma, Coagulation Control
Manufacturer
Accriva DiagnosticsModel number
DCJLR-ACatalog number
DCJLR-A
Lot number
J6DLA034
Product problems
- Human Factors Issue
- Human Factors Issue
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
(B)(4). ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE USING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. USAGE OF GLOVES OR THE PROTECTIVE SLEEVE PROVIDED WITH THE KIT WAS NOT SPECIFIED. THE LOCATION OF THE INJURY, THE SEVERITY OF THE INJURY AND THE INITIAL TREATMENT OF THE INJURY WAS NOT SPECIFIED. THE END USER WENT TO THE EMERGENCY ROOM, HOWEVER THE MEDICAL CARE THAT MAY HAVE BEEN RENDERED AND IF COMPLICATIONS OCCURRED WAS NOT SPECIFIED.