FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX I 725 CLINICAL SYSTEM
MDR report key: 2755190
·
Received September 23, 2012
Report
- Report Number
- 2050012-2012-01465
- Event Type
- Malfunction
- Date Received
- September 23, 2012
- Date of Event
- August 29, 2012
- Report Date
- August 29, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- CFR
- PMA / PMN Number
- K023049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: GLUCOSE MODULE.
Description of Event or Problem · 1
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LXI 725 CLINICAL SYSTEM (LXI #1) GENERATED ERRONEOUS GLUCOSE RESULTS. CUSTOMER REPORTED THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THEY REPEATED THE SAMPLES ON THE OTHER LX 20 SYSTEM (LXI #2). CUSTOMER REPORTED THE RESULTS GENERATED BY LXI #2 WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE GLUCOSE MODULAR REAGENT SYRINGE, CLEANED THE GLUCOSE ELECTRODE AND PERFORMED ALIGNMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX I 725 CLINICAL SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | CFR | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |