MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for BOX OF COLLECTION KITS, VAGINAL SWAB 301162 manufactured by Hologic, Inc.
[86251545]
The customer, (b)(6) at (b)(6), called to report one of their collection sites, (b)(6) hospital lab, had been using vaginal swab collection kits to collect endocervical specimens. The site had depleted their stock of unisex swab collection kits. Hologic technical support advised the customer that this is off label and that only the unisex swab collection kit should be used to collect endocervical swab specimens. The site ran off pi for about one week. The customer tested these swab specimens with the aptima combo 2 and aptima trichomonas vaginalis assays. Hologic evaluated this issue and determined the risk to be serious as an incorrect or invalid result due to improper or inadequate sample collection may result in a delay or failure to identify a condition that requires medical intervention. The customer may report incorrect patient results as the result of testing an improper sample type. Endocervical swab specimens collected using the aptima vaginal swab specimen collection have not been evaluated for use with the aptima combo 2 or aptima trichomonas vaginalis assays. Hologic ts advised the customer to use the correct type of swab only per pi.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00022 |
| MDR Report Key | 6867476 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-18 |
| Date Added to Maude | 2017-09-14 |
| 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 | 0 |
| Brand Name | BOX OF COLLECTION KITS, VAGINAL SWAB |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LIO |
| Date Received | 2017-09-14 |
| Catalog Number | 301162 |
| 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 DR SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-14 |