FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR VANCOMYCIN ASSAY
MDR report key: 1080211
·
Received July 17, 2008
Report
- Report Number
- 1219913-2008-00056
- Event Type
- Other
- Date Received
- July 17, 2008
- Date of Event
- June 18, 2008
- Report Date
- June 24, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.,
- Product Code
- LEH
- PMA / PMN Number
- K951059
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DIFFERENCES IN PATIENT RESULTS BETWEEN THE ADVIA CENTAUR AND THE ALTERNATE VANCOMYCIN METHODS IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
AN ADVIA CENTAUR VANCOMYCIN PATIENT RESULT WAS REPORTED TO THE PHYSICIAN THAT DID NOT MATCH THE CLINICAL CONDITION OF THE PATIENT. THE RESULT WAS QUESTIONED AND THE VANCOMYCIN TREATMENT WAS STOPPED. THE PATIENT SAMPLE WAS SENT TO A SISTER LAB, AND IT WAS TESTED WITH TWO OTHER VANCOMYCIN ASSAY METHODS AND THE RESULTS WERE LOWER THAN THE ADVIA CENTAUR METHOD. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED VANCOMYCIN RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR VANCOMYCIN ASSAY | VANCOMYCIN IMMUNOASSAY | LEH | SIEMENS HEALTHCARE DIAGNOSTICS INC., | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |