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 2017-02-27 for ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP) N/A 10309045 manufactured by Siemens Healthcare Diagnostics, Inc..
[68413978]
The cause for the elevated qc and patient results with advia centaur xp bnp reagent lot 188 and calibrator 38 lot 61 is unknown. Siemens continues to investigate. The limitations section of the instructions for use states: "the results of the advia centaur bnp assay should always be assessed in conjunction with the patient's medical history, clinical evaluation and other diagnostic procedures. "
Patient Sequence No: 1, Text Type: N, H10
[68413979]
Customer observed a high bias for a patient sample when using advia centaur xp bnp reagent lot ending in 188 when compared to the result using advia centaur bnp reagent lot ending in 186. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp bnp result.
Patient Sequence No: 1, Text Type: D, B5
[69788833]
Mdr 1219913-2017-00042 was filed on february 27, 2017 regarding a high bias for a patient sample when using advia centaur xp bnp reagent lot ending in 188 when compared to the result using advia centaur bnp reagent lot ending in 186. March 3, 2017 - additional information siemens performed a study using 3 lots of qc and 1 lot of medical decision pool (mdp) run in triplicate and 20 patient samples in singlicate (dose 10-360 pg/ml) with advia centaur bnp lots 185-191 with cal 61 and cal 62. Patient samples acceptable. Internal qc and mdps were in range on both lots. Assay works as specified. The customer is running a new lot number of reagent and produced qc within range.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2017-00042 |
| MDR Report Key | 6360639 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-27 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2016-07-07 |
| Date Added to Maude | 2017-02-27 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP) |
| Generic Name | BNP IMMUNOASSAY |
| Product Code | NBC |
| Date Received | 2017-02-27 |
| Model Number | N/A |
| Catalog Number | 10309045 |
| Lot Number | 51036188 |
| Device Expiration Date | 2017-07-07 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |