MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Orasure technologies inc., (oti) sales team received an email from ms.(b)(6) , an operations manager from red planet testing on (b)(6) 2023 and informed them that one of their patients used the intercept oral specimen collection device and had a severe allergic reaction.Ms.(b)(6) inquired if the intercept oral specimen collection device contained any iodine on the collection pad as the patient is severely allergic to iodine.On 15may2023, (b)(6) , the oti national account manager responded to ms.(b)(6) email and provided her with the ingredients listed on the intercept oral specimen collection device safety data sheet and informed her that iodine is not listed as an ingredient.Mr.(b)(6) also inquired if the patient was okay.Mr.(b)(6) additionally asked if a drug test (urine or oral fluid) was able to be performed on the patient.Ms.(b)(6) responded to mr.(b)(6) email on 15may2023 and informed him that as far as she was aware, the patient was fine after being treated for anaphylactic shock, and she was unaware if a drug test was performed.Ms.(b)(6) questioned mr.(b)(6) regarding the sds and wanted to know what common salts are used on the collection pad.Mr.(b)(6) emailed mr.(b)(6) , scientist iv at oti, and requested additional information on what common salts were used.Mr.(b)(6) informed ms.(b)(6) on 16may2023 that the collection pad is treated with potassium sorbate, sodium benzoate, sodium chloride, citric acid, and gelatin.Ms.(b)(6) responded on 16may2023 and asked if any of those compounds contained iodine.A response was not provided by mr.(b)(6).On 19july2023, ms.(b)(6) contacted ms.(b)(6) , the senior inside sales account manager at oti, and informed her that she had previously reached out to oti inquiring about ingredients, specifically iodine, that could be on the intercept collection pad.Ms.(b)(6) stated her patient presented her with a hospital bill in the amount of (b)(6).The patient stated ""i'm submitting it to our workers comp carrier for coverage but i'm guessing they are going to want to subrogate the claim." ms.(b)(6) wanted to know what oti chief scientist and legal counsel would say about the situation.Ms.(b)(6) responded to ms.(b)(6) on 21jul2023 and informed her that oti takes this matter very seriously, and an internal complaint investigation was initiated.Ms.(b)(6) provided ms.(b)(6) with the email address of the supervisor of complaint management at oti, (b)(6).Ms.(b)(6) informed ms.(b)(6) that oti provided the sds with her and there is no evidence of iodine in our intercept collection device.Ms.(b)(6) then encouraged ms.Urbach to contact (b)(6) if she has any additional questions.Oti customer quality became aware of the incident on 25jul2023, the same day as the initial submission of this report.Oti is currently performing an internal investigation to the complaint.The lot and item number of the intercept collection device has not been provided.A follow up is to be expected.

Event Description

Orasure technologies inc., (oti) sales team received an email from ms.(b)(6), an operations manager from (b)(6) testing on 15may2023 and informed them that one of their patients used the intercept oral specimen collection device and had a severe allergic reaction.Ms.(b)(6) inquired if the intercept oral specimen collection device contained any iodine on the collection pad as the patient is severely allergic to iodine.On (b)(6) 2023, (b)(4), the oti national account manager responded to ms.(b)(6) email and provided her with the ingredients listed on the intercept oral specimen collection device safety data sheet and informed her that iodine is not listed as an ingredient.Mr.(b)(4) also inquired if the patient was okay.Mr.(b)(4) additionally asked if a drug test (urine or oral fluid) was able to be performed on the patient.Ms.(b)(6) responded to mr.(b)(4) email on 15may2023 and informed him that as far as she was aware, the patient was fine after being treated for anaphylactic shock, and she was unaware if a drug test was performed.Ms.(b)(6) questioned mr.(b)(4) regarding the sds and wanted to know what common salts are used on the collection pad.Mr.(b)(4) emailed mr.(b)(4), scientist iv at oti, and requested additional information on what common salts were used.Mr.(b)(4) informed ms.(b)(6) on 16may2023 that the collection pad is treated with potassium sorbate, sodium benzoate, sodium chloride, citric acid, and gelatin.Ms.(b)(6) responded on 16may2023 and asked if any of those compounds contained iodine.A response was not provided by mr.(b)(4).On 19july2023, ms.(b)(6) contacted ms.(b)(4), the senior inside sales account manager at oti, and informed her that she had previously reached out to oti inquiring about ingredients, specifically iodine, that could be on the intercept collection pad.Ms.(b)(6) stated her patient presented her with a hospital bill in the amount of (b)(4).The patient stated " "i'm submitting it to our workers comp carrier for coverage but i'm guessing they are going to want to subrogate the claim." ms.(b)(6) wanted to know what oti chief scientist and legal counsel would say about the situation.Ms.(b)(4) responded to ms.(b)(6) on 21jul2023 and informed her that oti takes this matter very seriously, and an internal complaint investigation was initiated.Ms.(b)(4) provided ms.(b)(6) with the email address of the supervisor of complaint management at oti, (b)(4).Ms.(b)(4) informed ms.(b)(6) that oti provided the sds with her and there is no evidence of iodine in our intercept collection device.Ms.(b)(4) then encouraged ms.(b)(6) to contact (b)(4) if she has any additional questions.Oti customer quality became aware of the incident on 25jul2023, the same day as the initial submission of this report.Oti is currently performing an internal investigation to the complaint.The lot and item number of the intercept collection device has not been provided.A follow up is to be expected.

Manufacturer Narrative

Section g6 was corrected from 5-day to 30-day as instructed by (b)(6) in an email to ms.(b)(6) on 7/25/2023.8/9/2023: orasure technologies inc., (oti) customer care supervisor attempted to obtain a lot number of the intercept oral specimen collection device that was used on the patient.Ms.(b)(6) from (b)(6) testing provided lot number: pi220823.Oti customer quality representative confirmed that pi220823 is not an oti lot number.Ms.(b)(6) provided a picture of the lot number, which was applied to bubble wrap which contained the device.Oti customer care supervisor requested a picture of the actual device to confirm that the oral specimen collection device was in fact an oti product.On (b)(6) 2023, ms.(b)(6) notified oti customer care supervisor that all the devices had been used, and they had no additional photos or information to provide.Since (b)(6) testing could not provide a verified oti lot number, oti could not further investigate the claim of the customer or patient.This investigation will be closed internally by oti, and no further follow ups are to be expected.

Manufacturer Narrative

Section g6 was corrected from 5-day to 30-day as instructed by (b)(4) in an email to ms.(b)(6) on 7/25/2023.

Event Description

Orasure technologies inc., (oti) sales team received an email from ms.(b)(6), an operations manager from (b)(6) testing on (b)(6) 2023 and informed them that one of their patients used the intercept oral specimen collection device and had a severe allergic reaction.Ms.(b)(6) inquired if the intercept oral specimen collection device contained any iodine on the collection pad as the patient is severely allergic to iodine.On 15may2023, (b)(4), the oti national account manager responded to ms.(b)(6) email and provided her with the ingredients listed on the intercept oral specimen collection device safety data sheet and informed her that iodine is not listed as an ingredient.Mr.(b)(4) also inquired if the patient was okay.Mr.(b)(4) additionally asked if a drug test (urine or oral fluid) was able to be performed on the patient.Ms.(b)(6) responded to mr.(b)(4) email on (b)(6) 2023 and informed him that as far as she was aware, the patient was fine after being treated for anaphylactic shock, and she was unaware if a drug test was performed.Ms.(b)(6) questioned mr.(b)(4) regarding the sds and wanted to know what common salts are used on the collection pad.Mr.(b)(4) emailed mr.(b)(4), scientist iv at oti, and requested additional information on what common salts were used.Mr.(b)(4) informed ms.(b)(6) on 16may2023 that the collection pad is treated with potassium sorbate, sodium benzoate, sodium chloride, citric acid, and gelatin.Ms.(b)(6) responded on (b)(6) 2023 and asked if any of those compounds contained iodine.A response was not provided by mr.(b)(4).On (b)(6) 2023, ms.(b)(6) contacted ms.(b)(4), the senior inside sales account manager at oti, and informed her that she had previously reached out to oti inquiring about ingredients, specifically iodine, that could be on the intercept collection pad.Ms.(b)(6) stated her patient presented her with a hospital bill in the amount of (b)(6).The patient stated ""i'm submitting it to our workers comp carrier for coverage but i'm guessing they are going to want to subrogate the claim." ms.(b)(6) wanted to know what oti chief scientist and legal counsel would say about the situation.Ms.(b)(4) responded to ms.(b)(6) on 21jul2023 and informed her that oti takes this matter very seriously, and an internal complaint investigation was initiated.Ms.(b)(4) provided ms.(b)(6) with the email address of the supervisor of complaint management at oti, (b)(4).Ms.(b)(4) informed ms.(b)(6) that oti provided the sds with her and there is no evidence of iodine in our intercept collection device.Ms.(b)(4) then encouraged ms.(b)(6) to contact (b)(4) if she has any additional questions.Oti customer quality became aware of the incident on 25jul2023, the same day as the initial submission of this report.Oti is currently performing an internal investigation to the complaint.The lot and item number of the intercept collection device has not been provided.A follow up is to be expected.

Manufacturer Narrative

Section g6 was corrected from 5-day to 30-day as instructed by (b)(6) in an email to ms (b)(6) on 7/25/2023.8/9/2023 orasure technologies inc., (oti) customer care supervisor attempted to obtain a lot number of the intercept oral specimen collection device that was used on the patient.Ms.Urbach from red planet testing provided lot number pi220823.Oti customer quality representative confirmed that pi220823 is not an oti lot number.Ms.Urbach provided a picture of the lot number (attached), which was applied to bubble wrap which contained the device.Oti customer care supervisor requested a picture of the actual device to confirm that the oral specimen collection device was in fact an oti product.On 8/9/2023, ms.Urbach notified oti customer care supervisor that all the devices had been used, and they had no additional photos or information to provide.Since red planet testing could not provide a verified oti lot number, oti could not further investigate the claim of the customer or patient.This investigation will be closed internally by oti, and no further follow ups are to be expected.8/23/2023-update oti customer quality rep emailed clinical reference laboratory (crl) on 8/15/2023, to try and obtain the oti lot number of the oral specimen collection device.Crl purchased the oral specimen collection device from oti, and then redistributed the devices to the customer.Crl responded to customer quality on 8/23/2023 and informed them that crl lot pi220823 was created by 3 different oti lots (6694072 expiration: 1-31-2024, 6695154 expiration 2-29-2024, and 6694654 expiration 2-29- 2024).Since these three lot numbers were used to create crl lot pi220823, oti cannot definitively say which oti lot was used.After receiving the lot numbers provided by crl, customer quality reviewed the batch records and lot search for each lot, and there were no aberrant abnormalities observed.This complaint will be closed internally, no additional follow up is to be expected.

Event Description

Orasure technologies inc., (oti) sales team received an email from ms.(b)(4) an operations manager from red planet testing on (b)(6) 2023 and informed them that one of their patients used the intercept oral specimen collection device and had a severe allergic reaction.Ms.(b)(4) inquired if the intercept oral specimen collection device contained any iodine on the collection pad as the patient is severely allergic to iodine.On (b)(6) 2023, (b)(4) the oti national account manager responded to (b)(4) email and provided her with the ingredients listed on the intercept oral specimen collection device safety data sheet and informed her that iodine is not listed as an ingredient.Mr.(b)(6) also inquired if the patient was okay.Mr.(b)(6) additionally asked if a drug test (urine or oral fluid) was able to be performed on the patient.Ms.(b)(6) responded to mr.(b)(6) email on (b)(6) 2023 and informed him that as far as she was aware, the patient was fine after being treated for anaphylactic shock, and she was unaware if a drug test was performed.Ms.(b)(4) questioned mr.(b)(4) regarding the sds and wanted to know what common salts are used on the collection pad.Mr.(b)(4) emailed mr.(b)(4) scientist iv at oti, and requested additional information on what common salts were used.Mr.(b)(4) informed ms.(b)(4) on (b)(6) 2023 that the collection pad is treated with potassium sorbate, sodium benzoate, sodium chloride, citric acid, and gelatin.Ms.(b)(6) responded on (b)(6) 2023 and asked if any of those compounds contained iodine.A response was not provided by mr.(b)(4).On (b)(6) 2023, ms.(b)(6) contacted ms.(b)(6) the senior inside sales account manager at oti, and informed her that she had previously reached out to oti inquiring about ingredients, specifically iodine, that could be on the intercept collection pad.Ms.(b)(6) stated her patient presented her with a hospital bill in the amount of (b)(6).The patient stated ""i'm submitting it to our workers comp carrier for coverage but i'm guessing they are going to want to subrogate the claim." ms.(b)(4) wanted to know what oti chief scientist and legal counsel would say about the situation.Ms.(b)(4) responded to ms.(b)(6) on 15may2023 and informed her that oti takes this matter very seriously, and an internal complaint investigation was initiated.Ms.(b)(4) provided ms.(b)(6) with the email address of the supervisor of complaint management at oti, (b)(4).Ms.(b)(6) informed ms.(b)(4) that oti provided the sds with her and there is no evidence of iodine in our intercept collection device.Ms.(b)(6) then encouraged ms.(b)(4) to contact (b)(6) if she has any additional questions.Oti customer quality became aware of the incident on (b)(6) 2023, the same day as the initial submission of this report.Oti is currently performing an internal investigation to the complaint.The lot and item number of the intercept collection device has not been provided.A follow up is to be expected.

• Brand Name: INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE
• Type of Device: INTERCEPT
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jennifer krause ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 17391054
• MDR Text Key: 319706221
• Report Number: 3004142665-2023-00021
• Device Sequence Number: 1
• Product Code: PJD
• 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: Other
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 05/15/2023; 05/15/2023
• Supplement Dates FDA Received: 07/27/2023; 08/10/2023; 08/24/2023
• 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; Hospitalization; Other; Life Threatening