FDA Adverse Event
Malfunction
Summary report: N
ABL800 FLEX WITH FLEXQ MODULE
MDR report key: 1023678
·
Received April 1, 2008
Report
- Report Number
- 3002807968-2008-00007
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 2, 2008
- Report Date
- March 3, 2008
- Manufacturer
- RADIOMETER MEDICAL APS
- Product Code
- CHL
- PMA / PMN Number
- K043218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION ONGOING TO DETERMINE ROOT CAUSE.
Description of Event or Problem · 1
BLOOD GAS ANALYZER MEASUREMENTS ON AN ABL827 BLOOD GAS ANALYZER HAVE RESULTED IN MIX-UP OF PT ID DUE TO UNINTENDED REPEATED BARCODE READING OF THE SAMPLER PLACED IN THE FLEXQ TRAY SLOT 1. THE SAMPLER IN SLOT 1 WAS INCORRECTLY POSITIONED. WHEN ENTERING NEW SAMPLERS IN SLOT 2 AND 3, AND THEREBY INITIATING BARCODE READING OF THEIR PT ID, THE SAMPLER IN SLOT 1 WAS BLOCKING THE BARCODE READING. INSTEAD THE SOFTWARE ALLOWED THE BARCODE READER TO RE-SCAN THE BARCODE OF THE SAMPLER IN SLOT 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABL800 FLEX WITH FLEXQ MODULE | BLOOD GAS ANALYZER | CHL | RADIOMETER MEDICAL APS | ABL827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |