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

Model Number	DCJACT-A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Since this complaint is not related to product performance and the device will not be evaluated, this submission is considered a final report.
Event or Problem 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 not wearing gloves and did not use 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.When crushing the vial, 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 band aid.No further medical attention was sought.No significant blood loss or medical complications were reported.

• Brand Name: DIRECTCHECK ACT+ ABNORMAL
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 6996101
• Report Number: 2250033-2017-00006
• Device Sequence Number: 16468575
• Product Code: GGN
• UDI-Device Identifier: 10711234107058
• UDI-Public: 10711234107058
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K120977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: DCJACT-A
• Device Catalogue Number: DCJACT-A
• Device Lot Number: C7DCA008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR