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 2018-12-06 for ARCHITECT SYPHILIS TP 08D06-29 manufactured by Abbott Germany.
[130658657]
This report is being filed on an international product ln 8d06-29 that has a similar product in the us ln 8d06-31 and 8d06-41. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and sensitivity testing on lots 88489li00 and 89366li00. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. Both clinical seroconversion panels and in-house sensitivity testing met all specifications. No file kit testing could be performed for lot 82020li00 as this lot expired as of 2018-09-25. Return patient samples in (b)(6) are not allowed to be exported out of country due to (b)(6) government restrictions. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified. This event has been reported on 3 separate suspect medical devices, please also see the following manufacturer report numbers 3002809144-2018-00343 for lot 82020li00 3002809144-2018-00540 for lot 88489li00.
Patient Sequence No: 1, Text Type: N, H10
[130658658]
The customer observed a (b)(6) result on the architect i2000sr analyzer. The following data was provided sid (b)(6). (b)(6). There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2018-00541 |
| MDR Report Key | 8139966 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-12-06 |
| 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 | 2018-12-06 |
| Catalog Number | 08D06-29 |
| Lot Number | 89366LI00 |
| Device Expiration Date | 2019-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-12-06 |