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 2014-07-15 for ADVIA CENTAUR XP VB12 ASSAY N/A 09544818 manufactured by Siemens Healthcare Diagnostics, Inc..
[4536634]
The customer reported to siemens that they have a procedure to run quality control (qc) material with every preparation of advia centaur xp vitamin b12 (vb12) to ensure that it is prepared correctly before testing patient samples. This did not happen in this particular instance and patient samples were tested and results reported before qc was run and identified a preparation error. Results generated with the improperly prepared vb12 ancillary reagent showed a positive bias. There are no reports that patient treatment was altered or prescribed. There are no reports of adverse health consequences due to the vb12 discordant results.
Patient Sequence No: 1, Text Type: D, B5
[12039468]
The customer reported that the advia centaur vb12 releasing agent was probably not prepared correctly. There was failure to follow the customer's established procedure of running qc with every preparation of the advia centaur xp vb12 releasing agent prior to testing patient samples. When qc was performed on the releasing agent, the qc was out of specification. When qc was run with a fresh preparation of releasing agent, the results were in range. The quality control section of the instructions for use states: "if quality control results do not fall within the expected values or within the laboratory's established values, do not report results. Take the following actions: -verify that the materials are not expired. -verify that required maintenance was performed. -verify that the assay was performed according to the instructions for use. -rerun the assay with fresh quality control samples. -if necessary, contact your local technical support provider or distributor for assistance. " the limitations section of the ifu states: "preservatives, such as fluoride and ascorbic acid interfere with the advia centaur vb12 assay. Excessive exposure to light may alter vitamin b12 values. Dispose of the dtt/releasing agent ancillary reagent pack after 108 hours. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00184 |
| MDR Report Key | 3935242 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-06-27 |
| 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 |
| 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP VB12 ASSAY |
| Generic Name | VB12 IMMUNOASSAY |
| Product Code | CDD |
| Date Received | 2014-07-15 |
| Model Number | N/A |
| Catalog Number | 09544818 |
| Lot Number | 0132218 |
| ID Number | N/A |
| Device Expiration Date | 2014-06-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-07-15 |