MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-07-18 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[4598524]
Falsely high advia centaur xp folate red blood cell (rbc) results were observed by the customer on a patient sample. The initial test result on the rbc hemolysate sample was over-range and the auto dilution result was high, however, on repeat the test results were within range limits. The customer ran the patient sample on another advia centaur system and observed similar folate red blood cell (rbc) results. A new rbc hemolysate sample was prepared due to the false high test results and run on both advia centaur systems. The new hemolysate sample test results were lower. There are no known reports of patient treatment being altered or prescribed or adverse health consequences due to the high advia centaur xp folate results.
Patient Sequence No: 1, Text Type: D, B5
[12053459]
The cause for the initially false high (> 24) advia centaur xp folate red blood cell (rbc) results observed by the customer on the patient's rbc hemolysate test sample is unknown. Preventative maintenance was completed on both advia centaur systems and the customer's system maintenance was acceptable. The customer performed an rbc hemolysate auto dilution when the initial result was over-range, however this is considered a use error. No conclusion can be drawn. The instruction for use (ifu) states the following under the procedural notes for dilution and preparing the red blood cell hemolysate: "do not dilute the rbc hemolysate. " the advia centaur systems are performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00185 |
| MDR Report Key | 3943731 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-25 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-07-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. 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 FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY, PRODUCT CODE: |
| Product Code | CGN |
| Date Received | 2014-07-18 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 071227 |
| ID Number | N/A |
| Device Expiration Date | 2014-10-06 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-18 |