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.
[142608101]
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
[142608102]
The customer reported two samples which exhibited higher rlus on the negative ac2 assay. For the 1st sample, tested on (b)(6) 2019, the customer presented a sample id (b)(4) (m964616) which resulted ct negative in the aptima combo 2 assay with rlu 33 values. The same sample was sent to another laboratory (tampere) for testing on a different assay and the result came back ct positive. The customer provided run logs for analysis purposes. For the second sample, the customer obtained the following results for sample id (b)(4) aptima combo2 result run on (b)(6) 2019: the rlu was 9; ct: negative,gc: negative aptima ct results run on (b)(6) 2019: the rlu=6590 with ct: positive. 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 | 2024800-2019-00003 |
| MDR Report Key | 8533683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-19 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-15 |
| 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 | 8584108560 |
| 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 | 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 | R |
| 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 |