MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for PANTHER SYSTEM 902615 manufactured by Hologic, Inc..
[69373039]
Grifols' customer, (b)(6) reported during an ultrio elite assay run, that sample (b)(6) was misread as (b)(6) by the panther instrument. Customer identified this issue when the laboratory information system (lis) did not have a result for the sample (b)(6). At that time, they discovered the panther instrument misread as (b)(6). The number created by the panther did not exist in site as a donor system record. No incorrect result was reported out. Hologic sw team confirmed the issue was not software related but a possible firmware issue. Panther supplier was notified and further investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00009 |
| MDR Report Key | 6378241 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-03-03 |
| 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 | MKZ |
| Date Received | 2017-03-03 |
| Catalog Number | 902615 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2017-03-03 |