FDA Adverse Event
Summary report: N
IMMULITE 2000 ANALYZER
MDR report key: 438896
·
Received January 15, 2003
Report
- Report Number
- 2247117-2003-00001
- Date Received
- January 15, 2003
- Date of Event
- December 16, 2002
- Report Date
- January 8, 2003
- Manufacturer
- DPC INSTRUMENT SYSTEMS DIVISIONS
- Product Code
- JJQ
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IMMULITE 2000 OPERATOR WAS MOVING MONITOR AWAY FROM COVER ON THE IMMULITE 2000 ANALYZER AND THE TRAY HOLDING THE KEYBOARD AND MONITOR FELL. THE OPERATOR JUMPED OUT OF THE WAY, AND WAS STRUCK ON THE SIDE OF THEIR FACE NEAR THEIR EAR AND CHIN BY THE FALLING PARTS. THERE WAS NO BLOOD AND THE OPERATOR HAD A SMALL BUMP UNDER THEIR CHIN. THEIR NECK FELT A LITTLE STIFF FROM THEM JERKING THEIR HEAD TO AVOID THE COLLISION. THE OPERATOR WENT TO SEE AN ER PHYSICIAN TO BE EXAMINED, AND WAS TREATED FOR A BRUISED CHIN. DIAGNOSTIC PRODUCTS CORP DID NOT BECOME AWARE OF THIS INCIDENT UNTIL IT WAS REPORTED TO A TECHNICAL SERVICE REP IN 2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 ANALYZER | AUTOMATED ANALYZER FOR IVD USE. | JJQ | DPC INSTRUMENT SYSTEMS DIVISIONS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |