ORASURE
Report
- Report Number
- 3004142665-2021-00001
- Event Type
- Injury
- Date Received
- February 9, 2021
- Date of Event
- February 2, 2021
- Report Date
- March 22, 2021
- Manufacturer
- ORASURE TECHNOLOGIES, INC.
- Product Code
- MVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
Narratives
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.
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.
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.
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198255 | ORASURE | ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE | MVZ | ORASURE TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |