MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-19 for APTIMA COMBO 2 ASSAY 302661 manufactured by Hologic, Inc..
[142614334]
The customer reported three samples which exhibited higher than 10 rlus on the ac2 assay with negative results. Samples were rerun using the aptima ct assay and gave positive results. 2 samples were initially tested with ac2 on (b)(6) 2019 with results of 25 rlus each. Retest with act on (b)(6) 2019 resulted in 6895 rlus for the first sample and 6807 rlus for the second sample. 3rd sample was initially tested with ac2 on (b)(6) 2019 and resulted in 13 rlus. Retest with act on (b)(6) 2019 resulted in 7065 rlus. 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 | 2024800-2019-00005 |
| MDR Report Key | 8533442 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-19 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-19 |
| 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 | MS. 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 | 2019-04-19 |
| 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 | 2019-04-19 |