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 2019-04-09 for ARCHITECT SYPHILIS TP 08D06-77 manufactured by Abbott Germany.
[141366694]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete. This report is being filed on an international product, architect syphilis ln 08d06-39 that has a similar product distributed in the us, list numbers 08d06-31 and 08d06-41.
Patient Sequence No: 1, Text Type: N, H10
[141366695]
The customer observed (b)(6) syphilis results on the architect i2000sr analyzer. The following data was provided for a pregnant female: (b)(6). The tppa result for this specimen was (b)(6), and the additional results run for tpn15 and tpn17 were also (b)(6). There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00189 |
| MDR Report Key | 8495724 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-09 |
| Date of Report | 2019-06-28 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2018-11-21 |
| Date Added to Maude | 2019-04-09 |
| 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 | 2019-04-09 |
| Catalog Number | 08D06-77 |
| Lot Number | 95080LI01 |
| Device Expiration Date | 2019-10-22 |
| 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 | 2019-04-09 |