MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-30 for APTIMA COMBO 2 ASSAY 302661 manufactured by Hologic, Inc..
[146635334]
(b)(6), department of laboratory medicine, clinical microbiology, faculty of medicine and health, (b)(6) reported two aptima ac2 samples that had been sequenced and confirmed the finish variant that is currently under investigation by hologic. The finish variant is not picked up by the aptima ac2 test generating a ct/gc negative result, but is positive in an aptima ct re-test. An on-going investigation and risk assessment are in process at hologic regarding this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2019-00006 |
| MDR Report Key | 8656004 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-05-23 |
| Date Added to Maude | 2019-05-30 |
| 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 | APTIMA COMBO 2 ASSAY |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LSL |
| Date Received | 2019-05-30 |
| Catalog Number | 302661 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-05-30 |