MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK, PT ABNORMAL; PLASMA, COAGULATION CONTROL

Model Number DCJPT-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on 06/20/2016 references accriva diagnostics' complaint number (b)(4).Method: actual device not evaluated.No dhr review was required because the complaint is unrelated to product performance or packaging.Results: no results available since no evaluation performed.Conclusion: human factors issue.Device not returned.Accriva has requested all data required to complete form fda 3500a.

Event Description

Accriva's (b)(4) distributor reported that a healthcare professional (the end user) sustained an injury during reconstitution of 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 and was using the protective sleeve provided with the product.The end user sustained a small cut to the tip of her left index finger from a glass shard that protruded through the dropper vial and the protective sleeve.No significant blood loss or other medical complications were reported.This event occurred outside of the u.S.

• Brand Name: DIRECTCHECK, PT ABNORMAL
• 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: 5737134
• MDR Text Key: 47791804
• Report Number: 3002721930-2016-00008
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K944691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: DCJPT-A
• Device Catalogue Number: DCJPT-A
• Device Lot Number: J5DPA006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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