FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 800
MDR report key: 1424824
·
Received April 22, 2009
Report
- Report Number
- 1823260-2009-02873
- Event Type
- Malfunction
- Date Received
- April 22, 2009
- Date of Event
- April 3, 2009
- Report Date
- April 22, 2009
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE REP WAS UNABLE TO DETERMINED A CAUSE. HE CHECKED ALIGNMENT OF THE ROTOR, WORKSTATION ACCURACY, CLEANED ISE WASTE LINES, RAN ISE PERFORMANCE, CHECKED PROBES, TUBING, TUBE FITTING FOR ALL LINES ON THE FRONT PANEL. PERFORMED CHECK CASSETTE TESTS AND RAN QC TO VERIFY ANALYZER PERFORMANCE.
Description of Event or Problem · 1
USER RECEIVED 2 PT SAMPLES WITH ERRONEOUS RESULTS FOR MULTIPLE ASSAYS. THE FOLLOWING PT SAMPLE WAS DETERMINED TO BE DISCREPANT FOR AKALINE PHOSPHATASE (ALKP). INITIAL RESULT GAVE 409 U PER L. SAME SAMPLE WAS REPEATED FOUR TIMES USING SAME ANALYZER GIVING 153, 160, 157 AND 155 U PER L. THE INITIAL RESULTS WERE NOT REPORTED. THE REPEAT RESULTS WERE REPORTED. NO INFO PROVIDED TO DETERMINE WHICH REPEAT ALKP RESULT WAS REPORTED FOR THIS PT SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 800 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | I800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |