FDA Adverse Event
Malfunction
Summary report: N
PROFIBLOT II N
MDR report key: 906853
·
Received August 30, 2007
Report
- Report Number
- 3002710220-2007-00001
- Event Type
- Malfunction
- Date Received
- August 30, 2007
- Date of Event
- August 3, 2007
- Report Date
- August 30, 2007
- Manufacturer
- TECAN AUSTRIA GMBH
- Product Code
- MVW
- PMA / PMN Number
- K933996
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS BEING INVESTIGATED AND A 30 DAY FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PATIENT WESTERN BLOT TEST RESULT WAS REPORTED TO THE PHYSICIAN AS POSITIVE. THE PHYSICIAN REQUESTED THE WESTERN BLOT TEST BE REPEATED. THE REPEATED WESTERN BLOT SAMPLE TEST RESULT WAS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFIBLOT II N | VARIOUS WESTERN BLOT PROCESSOR | MVW | TECAN AUSTRIA GMBH | 16059001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |