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

Model Number	503-0509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient donor reported an allergic reaction after having the intercept test administered.The donor reported to have received the intercept test around approximately 10:45-11:00 am and left the physical examination around 11:49-11:56 am.At this point in time she noticed the swelling that was occurring of her lips on the side of the mouth where the test was administered.The donor took a benadryl later that afternoon (no time given) because the swelling had not subsided at that point in time.The donor reported at 11:00 pm the swelling had got worse and decided to go to the emergency room for treatment.The patient was in the emergency room until 12:35 pm which was approximately 12 hours after the test was administered.The emergency room administered a steroid and prilosec to coat the donors stomach and wrote out a prescription for an epi pen and benadryl for the allergic reaction.The patient donor took the prescribed benadryl and by 1:00 pm the following day the swelling had subsided.The epi pen prescription was given only as a precautionary measure by the emergency room.
Event or Problem Description
A patient donor reported an allergic reaction after having the intercept test administered.The donor reported to have received the intercept test around approximately 10:45-11:00 am and left the physical examination around 11:49-11:56 am.At this point in time she noticed the swelling that was occurring of her lips on the side of the mouth where the test was administered.The donor took a benadryl later that afternoon (no time given) because the swelling had not subsided at that point in time.The donor reported at 11:00 pm the swelling had got worse and decided to go to the emergency room for treatment.The patient was in the er until 12:35 pm which was approximately 12 hours after the test was administered.The er administered a steriod and prilosec to coat the donors stomach and wrote out a prescription for an epi pen and benadryl for the allergic reaction.The patient donor took the prescribed benadryl and by 1:00 pm the following day the swelling had subsided.The epi pen prescription was given only as a precautionary measure by the er.
Additional Manufacturer Narrative
The patient that experienced the allergic reaction was contaced via e-mail on (b)(6) 2020.The patient was asked about the extent of the reaction that occured and the current state of the symptoms.The safety data sheet for the intercept device was also provided to the patient at this time.Further information regarding any known allergies in which may have reacted with the intercept device was also requested.No response was received by the patient so a follow-up e-mai lwas sent on (b)(6) 2020.The patient responded that same day, (b)(6) 2020, and reported that all her symptoms have subsided and appreciated the correspondance.The patient also reported that she had no other side effects or symptoms from the incident.The benadryl and steriods that she received from the emergency room visit cleared up the reaction.The patient also stated that the epi pen that was also prescibed as a precautionary measure at the time of the er visit was never administered.A small raw lesion on the inside of the patients cheek was there for a few days but has since heeled.The patient reported that she feels fine currently as far as the allergic reaction goes.No other information on previous allergies or allergic reactions was provided by the customer.

• Brand Name: INTERCEPT
• Common Device Name: INTERCEPT ORAL FLUID DRUG TEST
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.; 220 east first street; bethlehem PA 18015 1696
• MDR Report Key: 10546883
• Report Number: 3004142665-2020-00005
• Device Sequence Number: 2992587
• Product Code: PJD
• UDI-Device Identifier: 00608337000078
• UDI-Public: 00608337000078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: 503-0509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other