MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-04-19 for ORAQUICK IN HOME HIV TEST manufactured by Orasure Technologies Inc..
[3276049]
Orasure's consumer call center (operated by (b)(6)) received an anonymous call at 17:38 on (b)(6) 2013, from a man inquiring about interpretation of results from a test stick that was allegedly found in his roommate's bathroom. The caller did not know how the test was performed or specifically when the test had been taken. The caller wanted to know if the call center operator could interpret the test result. The operator informed the caller that the test result is only valid for 40 minutes and therefore could not be interpreted after that time. The caller stated that his roommate had committed suicide and that he was trying to understand the reasons surrounding his death (and if the results could have had any role in his decision to commit suicide). The operator recommended a suicide hotline to discuss his questions with trained counselors as to why his friend may have taken his life. The caller indicated the he did not want the hotline contact information.
Patient Sequence No: 1, Text Type: D, B5
[10778320]
Due to the anonymous, confidential design of the call center operations, we are unable to verify the information provided by the caller or perform any additional investigation concerning this matter. We consider this report to be complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004142665-2013-00002 |
| MDR Report Key | 3074397 |
| Report Source | 00,04 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-15 |
| Date Mfgr Received | 2013-03-27 |
| Date Added to Maude | 2013-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELENA MACK, DIRECTOR |
| Manufacturer Street | 220 EAST FIRST STREET |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 6108821820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAQUICK IN HOME HIV TEST |
| Generic Name | ORAQUICK IN HOME HIV TEST (PR CODE MVZ) |
| Product Code | MVZ |
| Date Received | 2013-04-19 |
| ID Number | 1001-0340 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORASURE TECHNOLOGIES INC. |
| Manufacturer Address | BETHLEHEM PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-04-19 |