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 2017-06-02 for ADVIA CENTAUR XPT AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[76519148]
A siemens customer service engineer (cse) was sent to the customer's site for instrument inspection. Controls were tested in 10 replicates to check precision, and did not indicate a precision issue. There were no issues observed in the event log. The cse replaced the degasser, capsule filter, aspiration guide, pinch tubing, and adjusted the incubation ring and probes. The cse checked the b/f line, and fluid lines, and decontamination performed. The customer uses terumo blood (9 ml) collection tubes, and does not know how long the sample was allowed to clot before centrifugation. The terumo blood collection tube has a clot activator but does not have gel separator. The sample was centrifuged at 3,500 revolutions per minute (rpm) for 10 minutes. The cause for the discordant afp result is unknown. The non-reproduced elevated afp result may be attributed to insufficient clotting time and/or centrifugation. Siemens has recommended the customer allow samples to clot for at least 30 minutes before centrifugation, and centrifuge samples at 1000 x gravitational force (g) for 15-20 minutes. The instruction for use (ifu) states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics:? Samples are free of fibrin or other particulate matter. Remove particulates by centrifugation at 1000 x g for 15-20 minutes. ? Samples are free of bubbles. " 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. " the instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[76519149]
A falsely elevated advia centaur xpt alpha-fetoprotein (afp) result was observed on a patient sample. The patient sample was repeated on two other advia centaur systems and the results were lower. The lower result was reported to the provider. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xpt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00138 |
| MDR Report Key | 6607831 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-10 |
| Device Manufacturer Date | 2016-07-27 |
| Date Added to Maude | 2017-06-02 |
| 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 | 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT AFP ASSAY |
| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Product Code | LOK |
| Date Received | 2017-06-02 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 041182 |
| Device Expiration Date | 2017-10-27 |
| 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 | 2017-06-02 |