MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-09 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[4047544]
Customer observed an increase in the patient running mean for advia centaur xp folate when using reagent lot 071223 when compared to previous reagent lots. There are no known reports of patient treatment being altered or prescribed or adverse health consequences due to the increased advia centaur xp folate results.
Patient Sequence No: 1, Text Type: D, B5
[11369633]
The cause for the observed increase in the patient running mean for advia centaur xp folate when using reagent lot 071223 when compared to previous reagent lots is unknown and is currently under investigation. Additional representative data has been requested by siemens. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
[34904552]
Siemens filed the initial mdr 1219913-2014-00006 on january 9, 2014 for an increase in patient running mean for advia centaur xp folate whole blood cell samples when using reagent lot 071223 when compared to previously used reagent lots. April 9, 2014 - additional information customer patient running mean per reagent lot. Results do not include the whole blood cell calculation. Reagent lot number: 071211, ng/ml: 8. 33 , nmol/l: 18. 87; 071212, 8. 84, 20. 02; 071213, 7. 5, 16. 99; 071214, 7. 49, 16. 96; 071215, 8. 9, 20. 16; 071216, 9. 06, 20. 52; 071217, 8. 38, 18. 98; 071218, 7. 4, 16. 76; 071219, 9. 28, 21. 02; 071222, 12. 54, 28. 40; 071223, 12. 69, 28. 74; 071225, 12. 26 , 27. 77. 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 (b)(4) 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00006 |
| MDR Report Key | 3566494 |
| Report Source | 05,06 |
| Date Received | 2014-01-09 |
| Date of Report | 2012-12-12 |
| Date of Event | 2013-12-11 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-04-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1219913-03/25/2014-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2014-01-09 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 071223 |
| ID Number | N/A |
| Device Expiration Date | 2014-05-12 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-01-09 |