MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-03 for ELECSYS TOXO IGG IMMUNOASSAY 04618815190 manufactured by Roche Diagnostics.
Report Number | 1823260-2020-00026 |
MDR Report Key | 9545259 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2020-01-03 |
Date of Report | 2020-02-14 |
Date of Event | 2019-12-04 |
Date Mfgr Received | 2019-12-16 |
Date Added to Maude | 2020-01-03 |
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 | NA MICHAEL LESLIE |
Manufacturer Street | 9115 HAGUE ROAD NA |
Manufacturer City | INDIANAPOLIS IN 46250 |
Manufacturer Country | US |
Manufacturer Postal | 46250 |
Manufacturer Phone | 3175214343 |
Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
Manufacturer Street | SANDHOFERSTRASSE 116 NA |
Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
Manufacturer Country | GM |
Manufacturer Postal Code | 68305 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ELECSYS TOXO IGG IMMUNOASSAY |
Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII |
Product Code | LGD |
Date Received | 2020-01-03 |
Model Number | TOXO IGG |
Catalog Number | 04618815190 |
Lot Number | 394454 |
Device Expiration Date | 2020-02-29 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ROCHE DIAGNOSTICS |
Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-03 |