FDA Adverse Event
Malfunction
Summary report: N
BENCHMARK XT
MDR report key: 1053470
·
Received May 28, 2008
Report
- Report Number
- 2028492-2008-00003
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- April 30, 2008
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Product Code
- KPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY ANALYSIS INDICATES THE HEATER PADS WERE NOT OPERATING PROPERLY AND NEEDED TO BE REPLACED. THE INVESTIGATION IS ON-GOING.
Description of Event or Problem · 1
AN ADVERSE TREND FOR LIGHT STAINING AND INCONSISTENT STAINING WAS OBSERVED THROUGH MONITORING AND ANALYSIS OF INSTRUMENT SERVICE DATA. THE RISK ASSESSMENT PROCESS REQUESTED MEDICAL OPINION INDICATING THAT IF SAME SLIDE CONTROLS ARE NOT USED, THERE IS A POTENTIAL FOR A FALSE NEGATIVE RESULT. THE USE OF SAME SLIDE CONTROLS IS IN ALIGNMENT WITH THE (B) (4) AND THE (B) (4) AS STATED IN THE FEDERAL REGISTRY (SECTION 493. 1273; VOLUME 68, #16; 01/24/2003; PAGE 3709). THERE HAS BEEN NO REPORT OF MISDIAGNOSIS OR DELAY IN TREATMENT ASSOCIATED WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BENCHMARK XT | KPA - AUTOMATED STAINER | KPA | VENTANA MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |