MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK QUALITY CONTROL; DCJLR-N

Model Number DCJLR-N

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

The mdr submitted electronically on 02/10/2016 references (b)(4).Actual device not evaluated.Dhr review was performed.No ncr or any other anomalies related to the complaint were identified.No testing methods performed as the complaint is unrelated to product performance or packaging.(b)(4).Device not returned.Review of this case determined that the end user had not been trained on the proper method to crush the directcheck control vial.Accriva diagnostics has requested all data required for form 3500a.

Event Description

Healthcare professional reported that she (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 dropped vial containing diluent.The end-user was wearing gloves but due to a lack of training, she did not utilize 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 the upper portion of her right thumb, which was caused by a glass shard protruding through the dropper vial.The end user rinsed the area immediately, applied pressure to stop the bleeding, and covered the cut with a band aid.No significant blood loss or other medical complications were reported.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Type of Device: DCJLR-N
• 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: 5429170
• MDR Text Key: 38771312
• Report Number: 3002721930-2016-00002
• 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: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: DCJLR-N
• Device Catalogue Number: DCJLR-N
• Device Lot Number: E5DNL017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2015
• 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