FDA Adverse Event
Malfunction
Summary report: N
MAGNA PURE LC INSTRUMENT
MDR report key: 813522
·
Received November 12, 2004
Report
- Report Number
- 1823260-2004-01297
- Event Type
- Malfunction
- Date Received
- November 12, 2004
- Date of Event
- October 26, 2004
- Report Date
- October 26, 2004
- Manufacturer
- PRECISION SYSTEMS SCIENCES
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCOUNT HAS NOTICED THAT COLD STORAGE BLOCK AND POST ELUTION BLOCK ARE AT ROOM TEMPERATURE WHEN A RUN IS COMPLETE. A SOFTWARE BUG HAS BEEN IDENTIFIED WITH SOFTWARE VERSION 3.09 WHERE THE COOLING BLOCKS SHUT DOWN AFTER A UV DECONTAMINATION; LEAKAGE TEST OF Z-LEVEL ALIGNMENT AND DO NOT TURN BACK ON. HOWEVER, THE SYSTEM DISPLAYS THE COOLING BLOCK STATUS AS "PASS" INCORRECTLY INDICATING THAT THE COOLING BLOCKS ARE AT THE APPROPRIATE TEMPERATURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAGNA PURE LC INSTRUMENT | GENERAL PURPOSE INSTRUMENT | JJE | PRECISION SYSTEMS SCIENCES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |