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 2020-02-13 for ADVIA CENTAUR XPT TOTAL HCG (THCG) N/A 10308985 manufactured by Siemens Healthcare Diagnostics, Inc..
Report Number | 1219913-2020-00061 |
MDR Report Key | 9708572 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2020-02-13 |
Date of Report | 2020-03-12 |
Date of Event | 2020-01-22 |
Date Mfgr Received | 2020-02-18 |
Device Manufacturer Date | 2019-05-31 |
Date Added to Maude | 2020-02-13 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. EIMAN SULIEMAN |
Manufacturer Street | 333 CONEY STREET |
Manufacturer City | E. WALPOLE, MA |
Manufacturer Country | US |
Manufacturer Phone | 6604603 |
Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Manufacturer Street | 333 CONEY STREET |
Manufacturer City | E. WALPOLE, MA |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ADVIA CENTAUR XPT TOTAL HCG (THCG) |
Generic Name | TOTAL HCG |
Product Code | JHI |
Date Received | 2020-02-13 |
Model Number | N/A |
Catalog Number | 10308985 |
Lot Number | 18365309 |
Device Expiration Date | 2020-03-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-13 |