MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for TIGRIS INSTRUMENT SYS-CD 105118 manufactured by Hologic Incorporated.
[188375940]
Final report: on (b)(6) 2019, a customer reported failed runs on the tigris platform (sn: (b)(4)). The customer uploaded the logs from the affected runs and hologic determined that an ad injection issue had occurred causing some invalid samples and runs. In addition, a product application specialist (pas) noted the ad injection issue may also have affected five valid (b)(6) results and advised ts to request the customer to repeat testing of the samples with low s/co (signal/cut off). Repeat testing of the five samples by the customer produced (b)(6) results. The customer informed ts that the initial hpv results from (b)(6) 2019 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 (b)(6) 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 | 2024800-2020-00002 |
| MDR Report Key | 9575752 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-13 |
| Date Added to Maude | 2020-01-10 |
| 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 | MR. ABEL SALUTA |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108506 |
| Manufacturer G1 | HOLOGIC INC |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| 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 | 2020-01-10 |
| Catalog Number | 105118 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-10 |