MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC. INTERCEPT ORAL SPECIMEN COLLECTION DEVICE; NONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Palpitations (2467)

Event Date 12/04/2014

Event Type  Injury  

Event Description

An intercept test was administered to an employee for oral drug screening.After swabbing with the intercept device, the employee complained of a funny taste in her mouth that started to make her sick to her stomach.After the employee returned to her desk, she stated that her heart started fluttering and she started to feel really itchy.Within an hour of swabbing with the intercept device, the employee felt itchy all over.The employee contacted her doctor's office and was told that she was having a reaction and was instructed to come to the doctor's office immediately, but not drive herself and call 911 if she was experiencing difficulty breathing.

Manufacturer Narrative

The doctor treated the employee with an injection and a prescription to treat the reaction.A doctor's note was provided for the employee to take a few days off of work so the reaction could work itself out of the body.The employee returned to work the next day, (b)(6) 2014, but was still very ill.By (b)(6) 2104, the employee felt better.The employee has been working her regular schedule since and has not reported any additional symptoms.

• Brand Name: INTERCEPT ORAL SPECIMEN COLLECTION DEVICE
• Type of Device: NONE
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.; bethlehem PA 18015
• Manufacturer Contact: tiffany miller, dir, ra ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 4381194
• MDR Text Key: 5121322
• Report Number: 3004142665-2014-00007
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 12/30/2014
• 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): Required Intervention