Brand Name | XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) |
Type of Device | GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED |
Manufacturer (Section D) |
LUMINEX MOLECULAR DIAGNOSTICS |
12212 technology blvd. |
austin, TX 78727 |
|
MDR Report Key | 3678877 |
MDR Text Key | 19968547 |
Report Number | 3678877 |
Device Sequence Number | 3 |
Product Code |
PCH
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial |
Report Date |
03/05/2014 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Invalid Data
|
Device Catalogue Number | I032C0415 |
Device Lot Number | IK032C-008 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/06/2014 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/14/2014 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/06/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|