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 2018-12-27 for ADVIA CENTAUR XP AFP ASSAY N/A 10309980 manufactured by Siemens Healthcare Diagnostics, Inc..
[131943777]
The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result is unknown. The customer's assay calibration and quality controls (qc) were acceptable. A siemens application specialist was at the customer site previously, and observed an outlier when performing a precision check. A siemens customer service engineer (cse) checked the system, and no issues were observed. Siemens is investigating the event. The instruction for use (ifu) under the interpretation of results section states the following: "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
[131943778]
A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample. The customer performed repeat afp testing on the same sample, and instrument without additional sample centrifugation, and the results were lower. The elevated afp result was not reported to the physician. There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00307 |
| MDR Report Key | 8199490 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-27 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-12-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 AFP ASSAY |
| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN |
| Product Code | LOJ |
| Date Received | 2018-12-27 |
| Model Number | N/A |
| Catalog Number | 10309980 |
| Lot Number | 041199 |
| Device Expiration Date | 2018-05-15 |
| 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 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |