FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CALIBRATOR 1
MDR report key: 2120651
·
Received June 10, 2011
Report
- Report Number
- 2050012-2011-02172
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 11, 2011
- Report Date
- May 12, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- DEW
- PMA / PMN Number
- K965108
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT PROVIDE SAMPLE INFORMATION. CUSTOMER INDICATED QC SHIFTED HIGHER FOR TRANSFERRIN WITH THIS LOT OF CALIBRATOR. CUSTOMER DID NOT PROVIDE CALIBRATION DATA. NO OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS WERE NOTED. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME.
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) OBTAINING TRANSFERRIN RESULTS HIGHER WITH A NEW LOT OF CALIBRATOR FOR TWO (2) SAMPLES. RESULTS WERE NOT REPORTED OUT OF THE LAB. NO EFFECT TO PATIENTS WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CALIBRATOR 1 | MULTI-ANALYTE CALIBRATOR | DEW | BECKMAN COULTER INC. | NA | M005558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |