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 2018-10-24 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnotics, Inc.
[126238107]
A siemens customer service engineer went on site and did not identify any mechanical issues related to the event. Preventative maintenance was performed. Precision of calibration and qc was acceptable and no fliers were observed. The high level control was out of the 2sd range by less than 0. 5 sd and does not represent a flier. The level 1 control was within range on the day of the elevated patient result. The level 1 control is closer in value to the patient sample value and does not indicate an issue with the calibration. Root cause was not identified. Preanalytical variables cannot be ruled out. The issue is isolated to one sample. The system is operational and no further action or investigation is required. 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
[126238108]
Customer reported an elevated advia centaur xp alpha-fetoprotein (afp) result. The physician questioned the result. The sample was repeated and the result was lower and aligned with previous results. 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 | 1219913-2018-00265 |
| MDR Report Key | 8000908 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-09 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-10-24 |
| 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 | 2018-10-24 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 09370199 |
| Device Expiration Date | 2019-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-24 |