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

Model Number	DCJLR-A
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 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
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 6738933
• Report Number: 2250033-2017-00001
• Device Sequence Number: 1508732
• Product Code: GGN
• UDI-Device Identifier: 10711234107089
• UDI-Public: 10711234107089
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1