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

Model Number DCJLR-A

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 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted electronically on 03/16/2017 references accriva diagnostics' complaint number (b)(4).Method codes: actual device not evaluated.Dhr review was not performed because the complaint is unrelated to product performance or packaging.Results code: no results available since no evaluation performed.Conclusions codes: human factors issue.Training deficiency.Device not returned.Accriva diagnostics has requested all data required for form 3500a.

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 his left thumb, 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.He had blood drawn to test for (b)(6) , and his test results were (b)(6).No further medical care was reportedly provided.

Manufacturer Narrative

(b)(6) kilograms.

Event Description

Follow-up #1.

• Brand Name: HEMOCHRON DIRECTCHECK ACT-LR QUALITY CONTROL ABNORMAL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 6411842
• MDR Text Key: 70183291
• Report Number: 3002721930-2017-00004
• 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,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: H6DLA032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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: 45 YR
• Patient Weight: 133