MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-12 for AC2 302951 manufactured by Hologic, Inc..
[85797450]
(b)(6) reported that they had one ac2 assay run with more positives than normal (gc positive rate was 1%). The run (consisting of both swab and urine samples) done on the panther on (b)(6) 2017 was a valid run and the laboratory said that they didn't identify a pattern to the run. The laboratory released the results. A physician questioned four of the results for swab and urine samples and sent for new patient collections for these four questionable results. All four newly collected samples were tested as negative. When laboratory heard from the physician, they contacted hologic. Hologic reviewed the instrument logs for the run with the higher positivity rate which showed no instrument or reagent preparation related issue. There was no sign of gross contamination. Hologic requested the samples back (both the initial sample which tested positive and the sample taken from the re-test) and they were not available. Hologic could not confirm the initial or secondary sample test results. An incorrect result could be due to a kit or sample mishandling issue or the samples could be low titer samples. Hologic recommended customer to discard all open kits and clean the lab. Hologic investigated the ac2 kit associated with the report of a higher positivity rate, and did not determine any issues associated with the release of the kit. Hologic determined it was likely to be sample related issue due to contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00021 |
| MDR Report Key | 6858600 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-12 |
| 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 | AC2 |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-09-12 |
| Catalog Number | 302951 |
| Lot Number | 197107 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-09-12 |