MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-04 for ARCHITECT SYPHILIS TP 08D06-42 manufactured by Abbott Germany.
[134988874]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 08d06-42 that has a similar product distributed in the us, list number 08d06-41. Complete information for patient identifier = (b)(6). Patient information: no further patient information was provided.
Patient Sequence No: 1, Text Type: N, H10
[134988875]
The customer reported (b)(6) architect syphilis results. Sample id (b)(6) generated (b)(6) results on the architect assay ((b)(6)) and (b)(6) results on tpha and vdrl methods. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002809144-2019-00045 |
MDR Report Key | 8302720 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-02-04 |
Date of Report | 2019-05-22 |
Date of Event | 2019-01-12 |
Date Mfgr Received | 2019-05-14 |
Device Manufacturer Date | 2018-08-20 |
Date Added to Maude | 2019-02-04 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
Manufacturer City | ABBOTT PARK IL 600643537 |
Manufacturer Country | US |
Manufacturer Postal | 600643537 |
Manufacturer Phone | 224667-512 |
Manufacturer G1 | ABBOTT GERMANY |
Manufacturer Street | MAX-PLANCK-RING 2 |
Manufacturer City | WIESBADEN 65205 |
Manufacturer Country | GM |
Manufacturer Postal Code | 65205 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ARCHITECT SYPHILIS TP |
Generic Name | SYPHILIS |
Product Code | MTN |
Date Received | 2019-02-04 |
Catalog Number | 08D06-42 |
Lot Number | 91394LI00 |
Device Expiration Date | 2019-07-09 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ABBOTT GERMANY |
Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-02-04 |