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

Model Number DCJLR-N

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

Patient Problem Laceration(s) (1946)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted electronically on 04/21/2017 references accriva diagnostics' complaint number (b)(4).Method code: actual device not evaluated.Dhr review was not performed because the complaint is unrelated to product performance or packaging.Results code: no results available since no evaluation performed.Conclusion codes: human factors issue.Training deficiency.Device not returned.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 direct check quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.When reconstituting the control, the end-user wore gloves but failed to utilize the protective sleeve provided with the product.The purpose of the sleeve is to safeguard the end user against potential injury while handling the control.The end user squeezed the vial and sustained a small cut to her right index finger which was caused by a sharp piece of plastic.The end user washed the affected area with soap and water and applied a band aid.No other medical care was required and no complications were documented.

• Brand Name: DIRECTCHECK ACT-LR QUALITY CONTROL, NORMAL
• 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: 6513172
• MDR Text Key: 73510536
• Report Number: 3002721930-2017-00008
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234170243
• UDI-Public: 01107112341702431717083110M6DNL036
• 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: 04/19/2017

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: 08/31/2017
• Device Model Number: DCJLR-N
• Device Catalogue Number: DCJLR-N
• Device Lot Number: M6DNL036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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