FDA Adverse Event
Summary report: N
CENTRALINK
MDR report key: 2000887
·
Received February 24, 2011
Report
- Report Number
- 2432235-2011-00025
- Date Received
- February 24, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 27, 2010
- Manufacturer
- LRS HEALTH PTY, LTD
- Product Code
- JJE
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER(FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYSIS OF THE DATA FROM THE SIEMENS INSTRUMENTS, THE FSE DETERMINED THAT THERE WAS AN ERROR IN THE (B)(4) LABORATORY INFORMATION SYSTEM (LIS) SOFTWARE. THE (B)(4) LIS SOFTWARE WAS CORRECTED BY (B)(4) (THE MANUFACTURER OF THE LIS SYSTEM). ALL SIEMENS INSTRUMENTS ARE PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICES IS REQUIRED.
Description of Event or Problem · 1
THE (B)(6) REPORTED 11 INCORRECT RESULTS. AFTER THE ISSUE WAS DISCOVERED AND CORRECTED IN THE (B)(6), THE CORRECT RESULTS WERE REPORTED OUT. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE INCORRECT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRALINK | DATA MANAGER | JJE | LRS HEALTH PTY, LTD | MEDIPATH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |