inforMED
MalfunctionGGN

DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL

Received Sep 1, 2017 · Event occurred Aug 2, 2017

Report 2250033-2017-00004 · MDR key 6840403

Device

Generic name

Plasma, Coagulation Control

Model number

DCJLR-A

Catalog number

DCJLR-A

Product problems

  • Human Factors Issue
  • Adverse Event Without Identified Device or Use Problem
  • Human Factors Issue
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Laceration(s)
  • Laceration(s)

Narrative

Additional Manufacturer Narrative

THIS MDR SUBMITTED ELECTRONICALLY REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (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 DISPENSING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE REPORT DID NOT SPECIFY WHETHER THE END USER WORE GLOVES OR USED THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT WHEN RECONSTITUTING THE CONTROL. CIRCUMSTANCES OF THE INJURY WERE NOT SPECIFIED OTHER THAN THE INJURY OCCURRED ON THE SUBJECT'S RIGHT THUMB. IMMEDIATE AND FOLLOW-UP CARE WAS NOT SPECIFIED. NO COMPLICATIONS WERE DOCUMENTED. THREE CALLS WERE MADE TO THE END USER TO SEEK THE LOT NUMBER AND EXPIRATION DATA OF THE DEVICE IMPLICATED IN THIS COMPLAINT. THE END USER WAS NON-RESPONSIVE.