MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-23 for BENCHMARK ULTRA 05342716001 750-600 manufactured by Ventana Medical Systems Inc.
[103324625]
Detection of incorrect antibody dispense is highly dependent on presence of control tissue, type of control tissue, and antibodies dispensed. This could contribute to patient treatment decisions being made based on incorrect dispense.
Patient Sequence No: 1, Text Type: N, H10
[103324626]
Problem: customer reported anti-ema staining on two anti-s100 slides, no anti-s100 staining at all, anti-s100 seems not be applied on the slides but anti-ema seems to be applied instead. Investigation into the issue confirmed a software bug in which the wrong product is dispensed and the run report would only show the dispense of correct/intended stain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2018-00007 |
| MDR Report Key | 7366201 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-23 |
| 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 E 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 |
| 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 |
| Brand Name | BENCHMARK ULTRA |
| Generic Name | BENCHMARK ULTRA |
| Product Code | KPA |
| Date Received | 2018-03-23 |
| Model Number | 05342716001 |
| Catalog Number | 750-600 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 1. Other | 2018-03-23 |