MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEPCHECK P214 NORMAL CONTROL; PLASMA, COAGULATION CONTROL

Model Number DCP214-N

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Actual device not evaluated.No dhr review was required because the complaint is unrelated to product performance or packaging.No results available since no evaluation performed.Human factors issue.Device not returned.Accriva has requested all data required to complete form fda 3500a.

Event Description

A healthcare professional reported that she sustained a cut to her right middle finger while dispensing a directcheck quality control for a hemochron response and act coagulation system.This control is packaged in a glass ampule contained within a crushable plastic dropper vial containing diluent.The end-user was wearing gloves and when reconstituting the product had used the protective sleeve provided with the product.The injury was caused by a glass shard that protruded through the dropper vial when the control was being dispensed.The end user had removed the protective sleeve before squeezing the tube.No significant blood loss occurred.The end user washed her hand and applied a bandage.No other medical complications were reported.

• Brand Name: HEPCHECK P214 NORMAL CONTROL
• 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: 5867272
• MDR Text Key: 51837494
• Report Number: 3002721930-2016-00010
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/09/2016

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: 05/31/2017
• Device Model Number: DCP214-N
• Device Catalogue Number: DCP214-N
• Device Lot Number: D6DHN002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2016
• 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