MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. ORASURE; ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/02/2021

Event Type  Injury  

Event Description

A customer received a concern from one of their carriers requesting the msds sheet on the orasure hiv-1 device.An applicant they received was claiming they had an allergic reaction to the device after it was administered.The customer provided the orasure hiv-1 msds sheet to the carrier.An e-mail was sent to the customer on 02/02/2021 requesting further information on the allergic reaction claim.Information requested was as follows: implicated device lot number.Time frame of allergic reaction (exposure to the time of symptoms).Severity of allergic reaction (signs and symptoms).Medical attention sought, type and medical intervention prescribed (if any).Known allergies of the applicant.An e-mail was received on 02/08/2021 from the customer stating the applicant would not respond to any inquires and to close the investigation.At this time no further information is expected.

Manufacturer Narrative

Since an e-mail from the customer on (b)(6) 2021 stated the applicant would not respond to any inquiries and to close the investigation no further information has been received.At this time no further information is expected to be presented in order to continue an investigation.An e-mail from the customer on (b)(6) 2021 stated that they received some additional information from the applicant.The applicant stated that the allergic reaction started 3-5 minutes after being swabbed in the mouth by the test.A doctor recommended the applicant take an over the counter allergy medication (zyrtec) for the reaction.The applicant has no known allergies but intends on taking an allergy test.Pictures of the reaction were also included in the e-mail communication.An e-mail was sent in response to the customer's e-mail on (b)(6) 2021 requesting further information, specifically what the reaction symptoms were and whether or not the applicant took the suggested allergy medication.No response has been received to date.A follow-up e-mail was sent to the customer on 03/10/2021.No further information is expected at this time.

Event Description

A customer received a concern from one of their carriers requesting the msds sheet on the orasure hiv-1 device.An applicant they received was claiming they had an allergic reaction to the device after it was administered.The customer provided the orasure hiv-1 msds sheet to the carrier.An e-mail was sent to the customer on (b)(6) 2021 requesting further information on the allergic reaction claim.Information requested was as follows: implicated device lot number.Time frame of allergic reaction (exposure to the time of symptoms).Severity of allergic reaction (signs and symptoms).Medical attention sought, type and medical intervention prescribed (if any).Known allergies of the applicant.An e-mail was received on 02/08/2021 from the customer stating the applicant would not respond to any inquires and to close the investigation.At this time no further information is expected.

Manufacturer Narrative

Since an e-mail from the customer on 02/08/2021 stated the applicant would not respond to any inquiries and to close the investigation no further information has been received.At this time no further information is expected to be presented in order to continue an investigation.An e-mail from the customer on 02/24/2021 stated that they received some additional information from the applicant.The applicant stated that the allergic reaction started 3-5 minutes after being swabbed in the mouth by the test.A doctor recommended the applicant take an over the counter allergy medication (zyrtec) for the reaction.The applicant has no known allergies but intends on taking an allergy test.Pictures of the reaction were also included in the e-mail communication.An e-mail was sent in response to the customer's e-mail on 2/24/2021 requesting further information, specifically what the reaction symptoms were and whether or not the applicant took the suggested allergy medication.No response has been received to date.A follow-up e-mail was sent to the customer on 03/10/2021.No further information is expected at this time.An e-mail response from the customer on 03/17/2021 stated they carrier is getting no response from the applicant.At this time the customer asked to have orasure technologies, inc.Close the investigation.

Event Description

A customer received a concern from one of their carriers requesting the msds sheet on the orasure hiv-1 device.An applicant they received was claiming they had an allergic reaction to the device after it was administered.The customer provided the orasure hiv-1 msds sheet to the carrier.An e-mail was sent to the customer on 02/02/2021 requesting further information on the allergic reaction claim.Information requested was as follows: implicated device lot number.Time frame of allergic reaction (exposure to the time of symptoms).Severity of allergic reaction (signs and symptoms).Medical attention sought, type and medical intervention prescribed (if any).Known allergies of the applicant.An e-mail was received on 02/08/2021 from the customer stating the applicant would not respond to any inquires and to close the investigation.At this time no further information is expected.

Manufacturer Narrative

Since an e-mail from the customer on 02/08/2021 stated the applicant would not respond to any inquiries and to close the investigation no further information has been received.At this time no further information is expected to be presented in order to continue an investigation.

Event Description

A customer received a concern from one of their carriers requesting the msds sheet on the orasure hiv-1 device.An applicant they received was claiming they had an allergic reaction to the device after it was administered.The customer provided the orasure hiv-1 msds sheet to the carrier.An e-mail was sent to the customer on 02/02/2021 requesting further information on the allergic reaction claim.Information requested was as follows: implicated device lot number.Time frame of allergic reaction (exposure to the time of symptoms).Severity of allergic reaction (signs and symptoms).Medical attention sought, type and medical intervention prescribed (if any).Known allergies of the applicant.An e-mail was received on 02/08/2021 from the customer stating the applicant would not respond to any inquires and to close the investigation.At this time no further information is expected.

• Brand Name: ORASURE
• Type of Device: ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• MDR Report Key: 11300291
• MDR Text Key: 230944663
• Report Number: 3004142665-2021-00001
• Device Sequence Number: 1
• Product Code: MVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2021

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: No Information
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 02/02/2021; 02/02/2021
• Supplement Dates FDA Received: 02/22/2021; 03/11/2021; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1