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 Incorporated.
[142600803]
The decision to report this issue as an adverse event was made after information was provided to hologic on (b)(6) 2019 that the customer in finland identified a mutation that may affect results. No related complaints were reported in the us.
Patient Sequence No: 1, Text Type: N, H10
[142600804]
The customer contacted the local distributor that there were two ac2 sample results which were in question. Sample 1 was detected negative with the aptima ac2 test where the customers in house test (fromsynlab tallinn) was tested ct positive. Sample 2 was reported ct/gc negative with ac2 but tested positive on the synlab tallinn in-house 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 | 2024800-2019-00002 |
| MDR Report Key | 8533601 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-19 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| 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 | MR. ABEL SALUTA |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108506 |
| Manufacturer G1 | HOLOGIC INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAAN 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 | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-19 |