MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON DIRECTCHECK NORMAL ACT-LR; PLASMA, COAGULATION CONTROL

Model Number DCJLR-N

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted electronically on 01/12/2017 references accriva diagnostics' complaint number (b)(4).Actual device not evaluated.Dhr review was not performed because the complaint is unrelated to product performance or packaging.No results available since no evaluation performed.Human factors issue.Training deficiency.Device not returned.

Event Description

Healthcare professional reported that an end user sustained an injury during reconstitution of a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.The end-user was wearing gloves but did not utilize the protective sleeve provided with the product.The purpose of the sleeve is to safeguard the end user against potential injury during reconstitution of the control.The end user sustained a small cut to her right index finger, which was caused by a glass shard protruding through the dropper vial.The end user washed the affected area with soap and water and applied a band aid.No further medical care was reportedly provided.

• Brand Name: HEMOCHRON DIRECTCHECK NORMAL ACT-LR
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 squence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 6247736
• MDR Text Key: 64733962
• Report Number: 3002721930-2017-00002
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: DCJLR-N
• Device Catalogue Number: DCJLR-N
• Device Lot Number: J6DNL033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 60