MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-11 for PANTHER SYSTEM 902615 manufactured by Hologic, Inc.
[70014474]
Customer at dynalife diagnostics reported on (b)(6) 2017 that the patient's sample id did not match what was on the run report. The sample was run on (b)(6) 2017 and sample id on the run report was (b)(4) but should have been (b)(4) the sample was neg for both ct and gc. Customer retested the sample on (b)(6) 2017 for ct only, as the physician only requested ct only result. The result was negative and indicated the correct sample id (b)(4). The neg ct result has been reported to the physician. Fse sent the computer and a picture of the barcode samples to hologic for investigation. Review of customer run shows there were no issues with the scanner firmware or logs. Investigation showed that the panther software was functioning as intended. Hologic requested the barcodes for further investigation but they were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00011 |
| MDR Report Key | 6397708 |
| Date Received | 2017-03-11 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-10 |
| Date Added to Maude | 2017-03-11 |
| 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 DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| 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 | 0 |
| Brand Name | PANTHER SYSTEM |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-03-11 |
| Catalog Number | 902615 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2017-03-11 |