MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-28 for ADVIA CENTAUR XP BR N/A 10333349 manufactured by Siemens Healthcare Diagnostics, Inc..
[145246820]
Customer provided results for heterophilic ab testing: (b)(6). Siemens healthcare diagnostics is investigating. Mdr 1219913-2019-00046 (for test results on (b)(6) 2019) was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[145246821]
A falsely high patient sample result of >450 u/ml was obtained on (b)(6) 2019 using advia centaur xp br ((b)(4)) assay with reagent lot 047234 and calibrator lot cg40. The customer repeated testing of the sample with x10 and x20 automatic onboard dilutions and obtained over-dilution errors and repeated with a manual dilution, at 1:5 which resulted at 34. 5 u/ml. Repeat testing was performed on (b)(6) 2019 resulting in an additional high neat result and over-dilution error. The sample was later run on the same day on a different advia centaur and resulted at 7. 24 u/ml without over-dilution errors. False high results were not reported to the physician. There was no report of adverse health consequences due to the high patient result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00049 |
| MDR Report Key | 8462176 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-28 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-11-14 |
| Date Added to Maude | 2019-03-28 |
| 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. STACY LOUKOS |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086608576 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP BR |
| Generic Name | BR (CA 27.29) IMMUNOASSAY |
| Product Code | MOI |
| Date Received | 2019-03-28 |
| Model Number | N/A |
| Catalog Number | 10333349 |
| Lot Number | 047234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |