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

Model Number	DCJLR-A
Medical Device Problem Codes	Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr submitted electronically references accriva diagnostics' complaint number (b)(4).Accriva diagnostics has requested all data required for form 3500a.
Event or Problem Description
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.

• Brand Name: DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego 92121
• MDR Report Key: 6840403
• Report Number: 2250033-2017-00004
• Device Sequence Number: 18997681
• Product Code: GGN
• UDI-Device Identifier: 10711234107089
• UDI-Public: 10711234107089
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/31/2017

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 Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1