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

Model Number DCJLR-A

Device Problem Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

(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 using a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.Usage of gloves or the protective sleeve provided with the kit was not specified.The location of the injury, the severity of the injury and the initial treatment of the injury was not specified.The end user went to the emergency room, however the medical care that may have been rendered and if complications occurred was not specified.

• Brand Name: 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: 6738933
• MDR Text Key: 80968723
• Report Number: 2250033-2017-00001
• 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: 07/21/2017

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 Expiration Date: 03/31/2018
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: J6DLA034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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