MAUDE Adverse Event Report: MICROGENICS CORPORATION ORAL EZE ORAL FLUID COLLECTION SYSTEM; ORAL FLUID DRUGS OF ABUSE AND ALCOHOL TEST SPECIMEN COLLECTION DEVICE

Model Number 96100

Device Problem Device Handling Problem (3265)

Patient Problem Chemical Exposure (2570)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Emergency medical personnel were called, including ambulance and fire, alongside consulting with the cdc.Ems took patient's vitals and talked with him about his exposure to the sodium azide solution.Patient was cleared to safely leave.While sodium azide is a highly toxic substance, the amount available in the product is capable of causing hypotension, or other mild and reversible symptoms such as dizziness, mental status changes.

Event Description

Sample donor re-inserted the cotton swab of his completed drug test into his mouth after having immersed the swab in the 0.09% sodium azide preservation solution within the oral-fluid collection tube.

• Brand Name: ORAL EZE ORAL FLUID COLLECTION SYSTEM
• Type of Device: ORAL FLUID DRUGS OF ABUSE AND ALCOHOL TEST SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): MICROGENICS CORPORATION; 46500 kato road; fremont CA 94538
• Manufacturer Contact: dave schultenover ; 46500 kato road; fremont, CA 94538 ; 5109795000
• MDR Report Key: 10580917
• MDR Text Key: 208366425
• Report Number: 3010939897-2020-00001
• Device Sequence Number: 1
• Product Code: PJD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 96100
• Device Catalogue Number: 96100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other