MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-05-24 for 05265231001 750-700 manufactured by Ventana Medical Systems Inc.
[75918374]
Manufacturer's investigation into this issue is ongoing. The case states that the customer does not use the manufacturer's required package insert criteria for scoring conventions for the interpretation of pathway her2 (4b5) a detailed summary of the outcome of the investigation will be provided through the final report.
Patient Sequence No: 1, Text Type: N, H10
[75918375]
Customer is transferring breast work (her2, er and pr) from xt to ultra. Approx 50 cases have been used, some in parallel with current cases, but mostly retrospectively. Six (6) cases have been found to be discordant between the xt and ultra (in each case, what was reported as a her2 1+ on the xt was a 2+ on the ultra). Subsequent ddish testing has shown 2 of these cases to be amplified. One case has already resulted in a change of treatment following mdt meeting on (b)(6) 2017. The impact on patient treatment for the other case is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2017-00001 |
| MDR Report Key | 6590004 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-24 |
| 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 | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR NONE |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BENCHMARK XT |
| Product Code | MYA |
| Date Received | 2017-05-24 |
| Model Number | 05265231001 |
| Catalog Number | 750-700 |
| Lot Number | NA |
| ID Number | UDI 04015630981069 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |