MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-03 for PANTHER 303094 manufactured by Hologic, Inc..
[81728756]
Patient Sequence No: 1, Text Type: N, H10
[81728757]
We recently had an abnormally high number of (b)(6) results for (b)(6) culture with our standard nucleic acid probe test. We perform an average of 400-500 tests per month. In general, we have a (b)(6) rate, the number of (b)(6), however, varies significantly from run to run. This said, approximately two weeks ago, we had seven (b)(6) results out of 52 patients. This is higher than average. This consequently triggered us to inspect the run, which appeared otherwise normal (typical scattering of positive/negative results, controls worked appropriately). One of the ordering ob/gyns has re-tested two patients thus far, and both have comeback negative on repeat testing. After going through extensive data with the manufacturer of the instrument, they have reported that there was likely contamination of a lot of one of their reagents (lot number 197107, expiration date 07/15/2018, ref 303094). This lot has now been discarded from our facility, but it was used on test runs three separate dates. Out of concern for accuracy, the (b)(6) results from this testing will be given a disclaimer in the medical record stated that, "(b)(6) results may not be valid due to reagent contamination. Please consider re-testing if clinically appropriate. " we are now using a new lot of reagent and are watching our results closely. We have no reason to believe that our current reagent has been contaminated, but will of course look out for any unusual number of (b)(6). In addition, and out of an abundance of caution, any (b)(6) will be sent to a third party laboratory for confirmation. We are working with hologic to investigate a root cause. So far, we have confirmed the following: controls worked appropriately that day for the test batch the (b)(6) cases were spread throughout the test batch and showed no suspicious clustering to suggest contamination. Swabs were taken from the testing environment in the lab and these were negative for (b)(6), (which helps exclude local contamination) and that runs on previous/subsequent days appear normal. In addition to our efforts, the state department of public health conducted an onsite inspection approximately four days ago. It is our understanding that they were also unable to pinpoint a potential root cause relative to these presumed aberrant results. Manufacturer response for dna-reagents, (b)(4), panther (per site reporter). Working with the hospital to determine root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6763198 |
| MDR Report Key | 6763198 |
| Date Received | 2017-08-03 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-12 |
| Report Date | 2017-07-21 |
| Date Reported to FDA | 2017-07-21 |
| Date Reported to Mfgr | 2017-07-21 |
| Date Added to Maude | 2017-08-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANTHER |
| Generic Name | DNA-REAGENTS, NEISSERIA |
| Product Code | LSL |
| Date Received | 2017-08-03 |
| Catalog Number | 303094 |
| Lot Number | 197107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10808 WILLOW CT. SAN DIEGO CA 92127 US 92127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-03 |