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 2018-09-11 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnotics, Inc.
[119796244]
A siemens' customer service engineer (cse) went on site and ran background tests for dry, wet wash and water. All results fell within acceptable ranges. The customer told the cse that the sample was sent for confirmation testing on a different analyzer and the result was 1. 4 ng/ml. The cse noted dark material adhered to the side of the reagent readypack. The cse reviewed the event log around the time of the discrepant result and no events were noted. No issues noted upon review of calibration data. No problems found when a full system check was performed. Probe alignments were verified along with sample tip to cuvette alignment and centering. The sample syringe was lubricated. Five replicates of the patient sample were run and all results were less than 1. 3 ng/ml. The instrument is performing as expected. No further investigation is planned. The interpretation of results section of the instructions for use states: "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
[119796245]
Customer observed an initial elevated advia centaur xp afp result compared to duplicate, repeat testing of the sample. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00226 |
| MDR Report Key | 7863683 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2017-10-25 |
| Date Added to Maude | 2018-09-11 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 XP AFP ASSAY |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2018-09-11 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 78173196 |
| Device Expiration Date | 2019-01-25 |
| 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 DIAGNOTICS, INC |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |