MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK ACT+ ABNORMAL; PLASMA, COAGULATION CONTROL

Model Number DCJACT-A

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on 05/13/2016 references accriva diagnostics complaint number (b)(4).Actual device not evaluated.Process evaluation was not performed as the complaint is not related to product performance or packaging.No testing methods performed.Results: no results available since no evaluation performed.Conclusions: human factors issue.Training deficiency.Device not returned.Since this complaint is not related to product performance and the device will not be evaluated, this submission is considered a final report.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 dropped vial containing diluent.The end-user was wearing gloves and used the protective sleeve provided with the product.The purpose of the sleeve is to safeguard end users against potential injury during reconstitution of the control.After crushing the vial, the end user prematurely removed the protective sleeve.When he squeezed the vial to dispense the quality control material a glass shard protruded through the dropper vial and punctured the user's right thumb.The end user immediately washed the area with soap and water and covered the cut with a (b)(6).No further medical attention was sought.No significant blood loss or medical complications were reported.

• Brand Name: DIRECTCHECK ACT+ 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: 5655267
• MDR Text Key: 45193651
• Report Number: 3002721930-2016-00005
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: DCJACT-A
• Device Catalogue Number: DCJACT-A
• Device Lot Number: E5DCA008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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