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

Model Number	DCJLR-N
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	04/19/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 6513172
• Report Number: 3002721930-2017-00008
• Device Sequence Number: 747129
• Product Code: GGN
• UDI-Device Identifier: 10711234170243
• UDI-Public: 01107112341702431717083110M6DNL036
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1