MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK ACT-LR ABNORMAL QUALITY CONTROL; DCJLR-A

Model Number DCJLR-A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Dhr review was not performed as the complaint is unrelated to product performance or packaging.No testing methods performed.Results: no results available since no evaluation performed.Conclusions: 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 during reconstitution of a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropped vial containing diluent.The end-user was wearing gloves but it is unknown whether or not she utilized the protective sleeve provided with the product.The purpose of the sleeve is to safeguard end users against potential injury during reconstitution of the control.The end user sustained a small cut to an unspecified hand, which was caused by a glass shard protruding through the dropper vial.No other information was provided.

• Brand Name: DIRECTCHECK ACT-LR ABNORMAL QUALITY CONTROL
• Type of Device: DCJLR-A
• 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: 6126521
• MDR Text Key: 60867731
• Report Number: 3002721930-2016-00015
• Device Sequence Number: 1
• Product Code: GGN
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: C6DLA014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 50 YR