MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for PANTHER SYSTEM 902615 manufactured by Hologic, Inc.
[123069564]
Customer, associated pathologists, in (b)(6) has been experiencing misread sample ids on multiple panther instruments (3 units). The most recent event the sample (b)(4) was read as (b)(4). Usually, the sample turns [? ]white' on the panther sample screen when a misread happens. The operator would then manually enter the sample id number and test. In this event, the [? ]misread' matched a case in their lis and did not turn [? ]white' and the operator did not know this sample needed manual entry. The customer acknowledges the issue may be with the quality of their labels. As part of the investigation, the customer labels were returned to hologic and labels were graded. The labels passed the grading criteria. However, the customer does not use checksum format provided as a recommendation in the hologic's operator's manual. This use of checksum verification of the barcode would drastically reduce opportunities for sample id misreads. Hologic will recommend the customer use checksum as part of barcode verification. Further investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2018-00012 |
| MDR Report Key | 7940694 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-09-07 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | 0 |
| Brand Name | PANTHER SYSTEM |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2018-10-05 |
| Model Number | 902615 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 10210 GENETIC CENTER DR SAN DIEGO CA 92121 US 92121 |
| Brand Name | PANTHER SYSTEM |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2018-10-05 |
| Model Number | 902615 |
| Catalog Number | 902615 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-10-05 |