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 2018-12-13 for ARCHITECT SYPHILIS TP 08D06-29 manufactured by Abbott Germany.
[131545022]
A review of tickets determined no increase in complaint activity for lots: 86151li00 and 89366li00, and no trends were identified. The returned sample was tested with lot 89366li00, as the complaint lot: 86151li00 was not available, and (b)(6) results of (b)(6) were obtained. Sensitivity testing was performed on the returned sample with a retained kit of lot: 89366li00 with mikrogen recomline treponema igm/igg. The mikrogen recomline treponema igg showed a borderline, and mikrogen recomline treponema igm showed a (b)(6) result for the sample. Retained reagent kits of lot number 86151li00 and 89366li00 were previously tested in a sensitivity setup, including additional replicates of a sensitivity panel. Results of this setup did not show that the performance of the lots are negatively impacted. No (b)(6) results were obtained. A review of the manufacturing documentation did not identify any issues associated with the customer's observation. A review of labeling concluded that the issue is adequately addressed. Based on the investigation no product deficiency was identified for architect syphilis, lots: 86151li00 and 89366li00.
Patient Sequence No: 1, Text Type: N, H10
[131545023]
The customer reported (b)(6) architect syphilis results on one patient. The results provided were: architect = (b)(6)/roche, elisa, and tppa results are (b)(6). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2018-00548 |
| MDR Report Key | 8161991 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-12-13 |
| 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 |
| 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 | 2018-12-13 |
| Catalog Number | 08D06-29 |
| Lot Number | 89366LI00 |
| Device Expiration Date | 2019-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-13 |