MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC INTERCEPT; INTERCEPT ORAL FLUID DRUG TEST

Model Number 503-0509

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported on (b)(6) 2019 to orasure technologies, inc.That a customer had an allergic reaction to our intercept oral drug screen test.The employee was currently in the er with a swollen throat/tongue.The customer was provided the safety statement for the intercept oral swab device to determine if a component may caused the allergic reaction in the customer.The customer returned to work on (b)(6) 2019 but reported to still be shaking and swollen.The customer was still having symptoms as of (b)(6) 2019 and had made an appointment with a specialist for allergy testing to be completed.

Event Description

It was reported on (b)(6) 2019 to orasure technologies, inc.That a customer had an allergice reaction to our intercept oral drug screen test.The employee was currently in the er with a swollen throat/tongue.The customer was provided the safety statement for the intercept oral swab device to determine if a component may caused the allergic reaction in the customer.The cusotmer returned to work on (b)(6) 2019 but reported to still be shaking and swollen.The cusotmer was still having symptoms as of (b)(6) 2019 and had made an appointment with a specialist for allergy testing to be completed.

Manufacturer Narrative

It was reported on (b)(6) 2019 to oti that a customer had an allergic reaction to the intercept oral device.The employee was currently in the er with a swollen throat and tongue.The customer was provided the safety statement for the intercept oral swab device to try and determine a root cause of the allergic reaction the customer experienced.The customer returned to work on (b)(6) 2019 but reported to still be shaking and swollen.The customer was still having symptoms as of (b)(6) 2019 and had made an apointment with an allergy specialist for testing to be completed.The last patient update was received on (b)(6) 2019.The customer is currently undergoing allergy testing now to figure out what the reaction was caused by.A blood test for food/medicine ingested has already been completed with nothing coming back that she was allergic to.A second skin test was scheduled to be performed but there was no information as to whether this would conclude the skin testing or when results would be received.The customer was informed at this time that without further information this complaint would be closed.The customer reported that she would let us know if any further information was presented.Since no information was available on any possible allergies to any of the chemical components of the device, this will be resolved as unconfirmed.

• Brand Name: INTERCEPT
• Type of Device: INTERCEPT ORAL FLUID DRUG TEST
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC; 220 east first street; bethlehem PA 18015
• MDR Report Key: 8391484
• MDR Text Key: 137865960
• Report Number: 3004142665-2019-00002
• Device Sequence Number: 1
• Product Code: PJD
• Combination Product (y/n): N
• PMA/PMN Number: K011057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Notification
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 503-0509
• Device Lot Number: 0006667361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization