FDA Adverse Event
Malfunction
Summary report: N
BENCHMARK ULTRA SYSTEM
MDR report key: 23837289
·
Received December 18, 2025
Report
- Report Number
- 2028492-2025-05189
- Event Type
- Malfunction
- Date Received
- December 18, 2025
- Date of Event
- November 17, 2025
- Report Date
- March 30, 2026
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Product Code
- KPA
- UDI-DI
- 04015630981052
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE INVESTIGATION DETERMINED THAT THE PRODUCT IS MANUFACTURED BY A THIRD-PARTY, HUCKERT LABORATORY. THE MANUFACTURER WAS INFORMED OF THE ISSUE, AND THEY HAVE CONFIRMED THAT THE LABEL HAS BEEN UPDATED APPROPRIATELY. THERE IS NO INFORMATION TO REASONABLY SUGGEST A DEVICE MALFUNCTION AGAINST A ROCHE-MANUFACTURED PRODUCT.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF DISCREPANT HAZARDOUS LABELING ON THE UMONIUM 38 BOTTLE AND ITS MATERIAL SAFETY DATA SHEET (MSDS) THAT IS USED TO DECONTAMINATE THE BENCHMARK ULTRA INSTRUMENT. IT WAS REPORTED THAT THE BOTTLE IS MARKED ONLY WITH A SYMBOL INDICATING IT IS IRRITATING TO THE SKIN, WHILE THE MSDS INCLUDES ADDITIONAL SYMBOLS FOR CORROSIVE AND ENVIRONMENTALLY HAZARDOUS SUBSTANCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464468 | BENCHMARK ULTRA SYSTEM | SLIDE STAINER, AUTOMATED | KPA | VENTANA MEDICAL SYSTEMS INC. | 04015630981052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |