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 2019-01-17 for ARCHITECT SYPHILIS TP 08D06-39 manufactured by Abbott Germany.
[133854503]
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. The report is being filed on a similar product, ln 08d06-31 and 08d06-41 is on market in the usa.
Patient Sequence No: 1, Text Type: N, H10
[133854504]
The customer observed a (b)(6) result for one patient on the architect i2000sr analyzer. The following data was provided for a (b)(6) male patient: initial (b)(6), repeat (b)(6), (b)(6). The patient has a history of (b)(6) infection from a traumatic blood transfusion and gamma globulin therapy. The patient has received and is still undergoing treatment for (b)(6). There was no negative impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00016 |
| MDR Report Key | 8258306 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-17 |
| Date of Report | 2019-04-15 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2019-01-17 |
| 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 | 2019-01-17 |
| Catalog Number | 08D06-39 |
| Lot Number | 86151LI00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-17 |