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 2020-01-07 for LIPASE REAGENTS (4 X 160 TESTS) ADVIA CHEMISTRY XPT - LIPASE (LIP) 10311896 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2432235-2020-00006 |
| MDR Report Key | 9559450 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. MARDOCHEE TIMOLIEN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242503 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | 55 DIAMOND ROAD REGISTRATION # 8020890 |
| Manufacturer City | CRUMLIN, BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-01/02/2020-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPASE REAGENTS (4 X 160 TESTS) |
| Generic Name | ADVIA CHEMISTRY XPT - LIPASE (LIP) |
| Product Code | CHI |
| Date Received | 2020-01-07 |
| Model Number | ADVIA CHEMISTRY XPT - LIPASE (LIP) |
| Catalog Number | 10311896 |
| Lot Number | 485700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |