MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-14 for TIGRIS INSTRUMENT SYS-CD 105119 manufactured by Hologic, Inc.
[175229149]
Initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[175229150]
On (b)(6) 2019, a customer reported failed runs on the tigris platform (sn:(b)(4)) that occurred on (b)(6) 2019. The customer uploaded the logs from the affected runs and hologic determined that an ad injection issue had occurred causing invalid samples and runs. In addition, a product applications specialist (pas) confirmed a delay in light off in the affected run and identified 6 hpv samples whose results may be impacted. The customer informed ts that the hpv results were likely reported out; however, the customer did not know if any patients had been medically treated. Per risk assessment, the severity associated with a false positive result using the aptima hpv assay is serious. To mitigate this risk, hologic requested the customer to retest the samples in question; the customer retested the samples and made the necessary corrected reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2020-00003 |
| MDR Report Key | 9588287 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIGRIS INSTRUMENT SYS-CD |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | MZA |
| Date Received | 2020-01-14 |
| Catalog Number | 105119 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |