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 2018-01-19 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[97988908]
Siemens is investigating the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result. 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. " mdr 1219913-2018-00008 was filed for a repeat result from the same patient, and mdr 1219913-2018-00009 was filed for an additional result from the same patient on a different advia centaur system.
Patient Sequence No: 1, Text Type: N, H10
[97988909]
A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample, and the reported result was questioned by the physician. The customer performed repeat afp testing on the same instrument, serial sample dilutions, ran the sample on another advia centaur system, and the results were elevated. The patient sample was tested on two alternate afp test methods that resulted lower. A corrected report was issued. There is no report of patient treatment prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xp afp result. Mdr 1219913-2018-00008 was filed for a repeat on the same advia centaur xp system, and mdr 1219913-2018-00009 for a repeat on a different advia centaur system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00007 |
| MDR Report Key | 7208026 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-19 |
| Date of Report | 2018-02-09 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2018-01-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 NEURAL TUBE DEFECTS |
| Product Code | LOK |
| Date Received | 2018-01-19 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 041188 |
| Device Expiration Date | 2018-06-06 |
| 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 | 2018-01-19 |