MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON 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	Laceration(s) (1946)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr submitted electronically on 07/24/2017 references accriva diagnostics' complaint number (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 performing a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.The end-user was wearing gloves, but did not utilize the protective sleeve provided with the product.The purpose of the sleeve is to safeguard the end user against potential injury during reconstitution of the control.The end user sustained a puncture wound to the palm of her right hand, which was caused by a glass shard protruding through the dropper vial.The end user immediately washed her hands with chlorhexidine scrub and went to the emergency department to remove pieces of debris from the wound and further evaluation.Whether or not severe bleeding or other medical complication occurred was not specified.

• Brand Name: HEMOCHRON 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: 6738879
• Report Number: 2250033-2017-00003
• Device Sequence Number: 1490390
• 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): 07/24/2017

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: 07/11/2017
• 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