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

Model Number DCJLR-A

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted electronically references accriva diagnostics' complaint number (b)(4).Accriva diagnostics has requested all data required for form 3500a.

Event 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
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 6840403
• MDR Text Key: 86094142
• Report Number: 2250033-2017-00004
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234107089
• UDI-Public: 10711234107089
• 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: 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
• Device Operator: Health Professional
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: No
• 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