Brand Name | ARCHITECT SYPHILIS TP |
Type of Device | SYPHILIS |
Manufacturer (Section D) |
ABBOTT GERMANY |
max-planck-ring 2 |
wiesbaden 65205 |
GM 65205 |
|
MDR Report Key | 7634189 |
MDR Text Key | 112763022 |
Report Number | 3002809144-2018-00069 |
Device Sequence Number | 1 |
Product Code |
MTN
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup |
Report Date |
08/09/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/25/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/28/2018 |
Device Catalogue Number | 08D06-39 |
Device Lot Number | 82024LI00 |
Date Manufacturer Received | 08/07/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4) |
Patient Age | 45 YR |
|
|