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

Model Number DCJLR-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method codes: actual device not evaluated.Dhr review was not performed as the complaint is unrelated to product performance or packaging.Results code: no results available since no evaluation performed.Conclusion codes: human factors issue.Training deficiency.Device not returned.Review of this case determined that the end user had not been fully trained on the proper method to crush the directcheck act-lr abnormal control vial.Accriva diagnostics has requested all data required for form 3500a.

Event Description

Healthcare professional reported that an end user sustained a "pinch" injury to the right hand while attempting to activate a directcheck act-lr abnormal control.This control is packaged in a crushable vial containing a glass ampule.The end-user was utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution.When crushing the vial, the end user sustained a small cut to the right hand at the palm, which was caused by a glass shard protruding through the protective sleeve.The end user was not wearing gloves at the time of injury.The user washed the hand with soap and water, sanitized the area using an alcohol pad and affixed a band-aid.The end user did not seek further medical attention; accriva advised the healthcare professional reporting the event to follow their hospital's occupational injury policy.No significant blood loss occurred.There were no complications or other related medical issues.

• Brand Name: DIRECTCHECK QUALITY 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: 5321187
• MDR Text Key: 34920053
• Report Number: 3002721930-2015-00009
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2015

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: 06/30/2016
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: E5DLA015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2015
• 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