MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for PANTHER SYSTEM 902615 manufactured by Hologic Incorporated.
[87301056]
During a service visit at (b)(6) hospital (b)(6) ((b)(6)) on (b)(6) 2017, the high temp incubator was incorrectly replaced with an amp incubator on panther instrument s/n (b)(4). The incorrect incubator remained installed on the panther from (b)(6) 2017. Aptima combo 2? (ac2) assay was the only assay tested on the instrument during this period. The customer called hologic regarding a failing ac2 run on (b)(6) 2017. Based on troubleshooting at the customer site, and review of service records, it was identified on (b)(6) 2017 that an incorrect incubator was installed on the panther system. The incorrect incubator was replaced on (b)(6) 2017. The incorrect incubator was returned to hologic for evaluation and investigation. Based on the investigation studies completed at hologic on (b)(6) 2017, the use of the incorrect incubator resulted in suppressed assay control rlu values and at times invalid runs on the ac2 assay. Assessment finds the possibility of incorrect (false negative) test results reported and a remote probability that an incorrectly reported negative result could result in harm to patient health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00023 |
| MDR Report Key | 6892229 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-25 |
| 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 JILL WYLAND |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108487 |
| 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 |
| Removal Correction Number | 2024800-9/19/2017-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PANTHER SYSTEM |
| Generic Name | IN-VITRO DIAGNOSTIC, PRODUCT CODE |
| Product Code | MKZ |
| Date Received | 2017-09-25 |
| Catalog Number | 902615 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Brand Name | PANTHER SYSTEM |
| Generic Name | IN-VITRO DIAGNOSTIC, PRODUCT CODE: NSU |
| Product Code | NSU |
| Date Received | 2017-09-25 |
| Catalog Number | 902615 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO, CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |