FDA Adverse Event
Other
Summary report: N
AEROSET ANALYZER
MDR report key: 296970
·
Received September 14, 2000
Report
- Report Number
- 1628664-2000-00057
- Event Type
- Other
- Date Received
- September 14, 2000
- Date of Event
- August 14, 2000
- Report Date
- September 13, 2000
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THIS CUSTOMER OBTAINED A LOW POTASSIUM RESULT ON THE AEROSET ANALYZER. A RESULT OF 2.8MMOL/L WAS REPORTED OUT OF THE LAB. THE LAB THEN RERAN THE SAMPLE AND A RESULT OF 4.6MMOL/L WAS OBTAINED. THE SAMPLE WAS ALSO RUN ON A SECOND ANALYZER WHICH PRODUCED RESULTS THAT MATCHED THE REPEAT RESULT OF 4.6MMOL/L. THE CORRECTED RESULT WAS IMMEDIATELY REPORTED. THERE HAS BEEN NO REPORT OF IMPACT TO THE PT OR PT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AEROSET ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | ABBOTT MANUFACTURING, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |