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 2019-03-24 for ARCHITECT SYPHILIS TP 08D06-39 manufactured by Abbott Germany.
[139702696]
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 8d06-39 that has a similar product distributed in the us, list number 8d06-41. There is no further patient information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[139702737]
The customer reported false nonreactive architect syphilis results on one patient. The results provided were: architect = nonreactive / weigao method = positive. The customer believes the architect results are correct based on the patient's clinical data. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002809144-2019-00118 |
MDR Report Key | 8446723 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-03-24 |
Date of Report | 2019-04-22 |
Date Mfgr Received | 2019-04-03 |
Device Manufacturer Date | 2018-09-11 |
Date Added to Maude | 2019-03-24 |
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 | 2019-03-24 |
Catalog Number | 08D06-39 |
Lot Number | 91382LI00 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
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 | 2019-03-24 |