FDA Adverse Event
Other
Summary report: N
SYSMEX CA-1500
MDR report key: 509828
·
Received January 20, 2004
Report
- Report Number
- 1422681-2003-00004
- Event Type
- Other
- Date Received
- January 20, 2004
- Date of Event
- December 4, 2003
- Report Date
- January 13, 2004
- Manufacturer
- SYSMEX CORPORATION
- Product Code
- JPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER CORRECTLY REPORTED AN ERROR MESSAGE (CODE 128) ON A PT SAMPLE DURING APTT TESTING WITH ACTIN FSL. CONTRARY TO INSTRUCTIONS PROVIDED BY THE MANUFACTURER (SYSMEX CORPORATION) THE LABORATORY TECHNICIAN IGNORED THE RESULT FLAG AND MANUALLY CALCULATED THE RESULT. THIS LED TO THE REPORTING OF AN INCORRECT RESULT, THE PT WAS OVER-HEPARINIZED AND SUBSEQUENTLY BLED. PT RECEIVED MEDICAL INTERVENTION IN THE FORM OF THREE UNITS OF RBCS TO STABILIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSMEX CA-1500 | AUTOMATED COAGULATION ANALYZER | JPA | SYSMEX CORPORATION | CA-1500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |