MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-03 for APTIMA COMBO 2 301041-01 manufactured by Hologic, Inc..
[104214777]
Customer, (b)(6), called to report that one of their technicians was using the aptima unisex collection kit to collect a rectal patient sample, which is not consistent with the collection kit package insert. The operator ((b)(6)) collected the patient swab and placed the swab into the collection tube. Prior to closing the collection tube, transport media containing the patient swab splashed into the operator's eye. The operator then washed her eye with water and cleaned the skin with soap and water. The operator was wearing glasses at the time of sample collection, but was not wearing safety glasses. The patient sample was tested with the aptima combo 2 (ac2) assay, and the results were dual (b)(6) for (b)(6). The operator was examined by a doctor and will continue to be monitored, but no medications or antibiotics have been prescribed. Per hologic's risk assessment, as a result of patient sample exposure, the operator may have been infected. The sample is known to be (b)(6) for (b)(6), but the presence of other potentially infectious organisms cannot be known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2018-00004 |
| MDR Report Key | 7393103 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-03-07 |
| Date Added to Maude | 2018-04-03 |
| 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 |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | LIO |
| Date Received | 2018-04-03 |
| Catalog Number | 301041-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-03 |