FDA Adverse Event
Malfunction
Summary report: N
IMMAGE IMMUNOCHEMISTRY SYSTEM
MDR report key: 2440231
·
Received February 6, 2012
Report
- Report Number
- 2050012-2012-00416
- Event Type
- Malfunction
- Date Received
- February 6, 2012
- Date of Event
- January 20, 2012
- Report Date
- January 20, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQX
- PMA / PMN Number
- K962294
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES, RESULTS, CODE 100 (OTHER): LOOSE WASTE TRAP FITTING. (B)(4).
Description of Event or Problem · 1
ON (B)(4) 2012, CUSTOMER REPORTED THAT THE IMMAGE 800 INSTRUMENT GENERATED "VACUUM OUT OF RANGE LOW" ERRORS WHEN THE WASH SOLUTION WAS PRIMED, AND THAT THE PROBES ALSO LEAKED. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND A LOOSE WASTE TRAP FITTING. FSE REPAIRED THE FITTING AND NO FURTHER LEAKS WERE REPORTED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMAGE IMMUNOCHEMISTRY SYSTEM | NEPHELOMETER, FOR CLINICAL USE | JQX | BECKMAN COULTER, INC. | IMMAGE 800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |