MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-10 for ADVIA CENTAUR FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[4075943]
The customer observed an advia centaur folate (rbc) whole blood positive bias of approximately 30% when performing a reagent folate lot patient correlation study. Two additional advia centaur folate reagent lots were provided for repeat folate (rbc) whole blood patient correlation studies and a positive bias was also observed for each reagent lot. The customer also observed higher quality control recovery with folate whole blood (rbc) controls compared to peer quality control data, however, the results were within quality control product insert ranges. There was no known report of patient treatment being altered or adverse health consequences due to the advia centaur folate (rbc) whole blood higher patient results.
Patient Sequence No: 1, Text Type: D, B5
[11364059]
The cause for the advia centaur folate (rbc) whole blood positive patient reagent lot bias and higher folate (rbc) quality control recovery compared to peer data is unknown and siemens is currently investigating. No conclusion can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
[34904905]
Siemens filed the initial mdr 1219913-2014-00005 on 01/10/2014 for an advia centaur folate whole blood cell positive patient and qc bias. On 04/09/2014 - additional information: based upon additional information and investigation, on march 25, 2014, siemens issued an urgent medical device recall (108180053) to its customers in the united states and an urgent field safety notice (10818055) to its customers outside of the united states, related to the advia centaur folate assay. Siemens has determined that the advia centaur systems folate assay, kit lots ending in 222, 224, 225, 226 and/or 227, meets the published claims in the ifu for normal whole blood cell folate. The whole blood cell folate results for lots ending in 219 may show a negative bias of up to 41. 2% relative to new lots 224, 225, 226, and 227. This negative bias may result in a patient receiving folate supplementation; however, this supplementation does not constitute a risk to health. The bio-rad lyphochek whole blood control lot 73210 insert control values were updated based on current unity peer data and internal confirmation testing. Bio-rad lyphochek whole blood control manufacturer updated qc insert values advia centaur /centaur xp: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00005 |
| MDR Report Key | 3569012 |
| Report Source | 05,06 |
| Date Received | 2014-01-10 |
| Date of Report | 2013-12-03 |
| Date of Event | 2013-12-03 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-04-16 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | 1219913-03/25/2014-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY, PRODUCT CODE: |
| Product Code | CGN |
| Date Received | 2014-01-10 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 222, 223, 225 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-01-10 |