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 2018-03-16 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[102725392]
A siemens customer service (cse) was sent to the customer site for system inspection. The cse checked the sample probe to cuvette bottom alignment, the reagent probe 1 (rp1), and the wash dispenses and aspirations. The cse checked the vertically up and down in the sample probe, observed some excessive play left to right, and replaced the sample probe leadscrew, and tightened the pulley. A precision check of 40 replicates was run and the results were acceptable. While the loose pulley and leadscrew could have caused the false low result, this was not confirmed. The cause for the non-reproduced false low advia centaur xp result is unknown. 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
[102725393]
A false low advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample. The customer performed repeat afp testing on the same patient sample and the result was elevated. The initially low afp result was not reported to the physician. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00112 |
| MDR Report Key | 7345420 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2018-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| 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 | LOJ |
| Date Received | 2018-03-16 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 041193 |
| Device Expiration Date | 2018-11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Brand Name | ADVIA CENTAUR XP AFP ASSAY |
| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Product Code | LOK |
| Date Received | 2018-03-16 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 041193 |
| 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 | 2018-03-16 |