FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR HAV IGM ASSAY
MDR report key: 1315783
·
Received February 17, 2009
Report
- Report Number
- 1219913-2009-00014
- Event Type
- Other
- Date Received
- February 17, 2009
- Date of Event
- January 26, 2009
- Report Date
- January 27, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- LOL
- PMA / PMN Number
- K081716
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DECLINED SERVICE - NO FURTHER ACTION TAKEN. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR (B)(6) IGM RESULT IS UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. A SAMPLE FROM THIS PT HAS BEEN REQUESTED FOR FURTHER EVAL.
Description of Event or Problem · 1
A REACTIVE ADVIA CENTAUR (B)(6) IGM RESULT AND A NON-REACTIVE (B)(6) TOTAL RESULT WERE OBTAINED FOR A PT SAMPLE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) 1GM RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR HAV IGM ASSAY | HEPATITIS A VIRUS IGM ASSAY | LOL | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |