FDA Adverse Event
Malfunction
Summary report: N
CD 3700 SL
MDR report key: 1051532
·
Received May 18, 2008
Report
- Report Number
- 2919069-2008-00460
- Event Type
- Malfunction
- Date Received
- May 18, 2008
- Date of Event
- January 22, 2008
- Report Date
- February 19, 2008
- Manufacturer
- ABBOTT DIAGNOSTICS DIV/CELLDYN
- Product Code
- GKZ
- PMA / PMN Number
- K980614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATED WHEN RUNNING A PT SAMPLE IN CLOSED MODE ON THE CELL-DYN 3700 ANALYZER, A DIFFERENT BARCODE NUMBER (SPECIMEN ID) WAS PRINTED ON THE REPORT BETWEEN THE INITIAL AND RETEST. AN INCORRECT SAMPLE ID OF 2001096275 PRINTED ON THE INITIAL REPORT BUT UPON RETEST, THE CORRECT SPECIMEN ID OF 2001095275 WAS PRINTED. NO IMPACT TO PT MGMT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD 3700 SL | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIV/CELLDYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |