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 2018-06-05 for ADVIA CENTAUR XP AFP ASSAY N/A 10309980 manufactured by Siemens Healthcare Diagnostics, Inc..
[110172410]
A siemens field service engineer (fse) was sent to the customer site for system inspection. The fse verified good wash block function. The fse made adjustments to the reagent probe 1 calibration. The customer replaced the afp reagent and ran all quality control (qc). The qc passed. The customer ran afp x5 on 4 patients. Precision is good. The customer confirmed afp is functioning properly on the analyzer. The customer had a sample that recovered 1. 9 ng/ml when originally tested with advia centaur xp alpha-fetoprotein (afp) lot 193 but 3. 0 ng/ml when retested. Two other samples showed similar differences. Siemens does not have any precision claims for the advia centaur xp afp assay with samples < 16. 5 ng/ml. The values for the samples are well within the normal range (0 - 8. 0 ng/ml) listed in the advia centaur xp afp instructions for use (ifu) so there is no change in clinical interpretation. The cause of the difference in the values cannot be determined but there is no indication it is abnormal performance. Based on the available information advia centaur xp alpha-fetoprotein (afp) lot 193 is performing as intended. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[110172411]
A low advia centaur xp afp result was obtained for a patient sample. The customer repeats any sample with a result less than three. The patient sample was repeated and the result was higher. The initial result was reported to the physician and was not questioned. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00163 |
| MDR Report Key | 7568996 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-18 |
| Date Added to Maude | 2018-06-05 |
| 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 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. 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 AFP ASSAY |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2018-06-05 |
| Model Number | N/A |
| Catalog Number | 10309980 |
| Lot Number | 48772193 |
| Device Expiration Date | 2018-11-17 |
| 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 | 2018-06-05 |