MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for ADVIA CENTAUR XP VB12 ASSAY N/A 09544818 manufactured by Siemens Healthcare Diagnostics, Inc..
[49157546]
The acceptable qc results, and consistent results with other samples on may 6 and 10 indicate an issue with the samples. The qc passed on all testing days which indicates valid performance of the reagents. This likely appears to be a sample or sample handling issue. The upward trend in dose over time may indicate non-homogenous sample issue, i. E. Proper mixing, or potentially an interference listed in the instructions for use (ifu). For accession (b)(4), the sample was collected on (b)(6) 2016 and received date on (b)(6) 2016 (more than 48 hrs). This sample exceeds the limit in the specimen collection and handling section of the instructions for use. The other two samples (b)(6) were collected on (b)(6) 2016 and received date on (b)(6) 2016 (within 48 hrs). Additionally, as listed in the limitations section in the instructions for use: "preservatives, such as fluoride and ascorbic acid interfere with the advia centaur vb12 assay. Excessive exposure to light may alter vitamin b12 values. " the preparing the samples section of the instructions for use states: "before placing samples on the system, ensure that samples have the following characteristics: samples are free of fibrin or other particulate matter. Samples are free of bubbles. " "serum, heparinized plasma, or edta plasma are the recommended sample types for this assay. The following recommendations for handling and storing blood samples are furnished by the (b)(4): collect all blood samples observing universal precautions for venipuncture. Allow samples to clot adequately before centrifugation. Keep tubes stoppered and upright at all times. Do not use samples that have been stored at room temperature for longer than 8 hours. Tightly cap and refrigerate specimens at 2-8? C if the assay is not completed within 8 hours. Freeze samples at or below -20? C if the sample is not assayed within 48 hours. Freeze samples only once and mix thoroughly after thawing. "
Patient Sequence No: 1, Text Type: N, H10
[49157547]
The customer reported non-reproducible results using the advia centaur xp vitamin b12 (vb12) assay. There are no reports that treatment was altered or prescribed based on the non-reproducible advia centaur xp vb12 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2016-00113 |
| MDR Report Key | 5760000 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-06-29 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP VB12 ASSAY |
| Generic Name | VB12 IMMUNOASSAY |
| Product Code | CDD |
| Date Received | 2016-06-29 |
| Model Number | N/A |
| Catalog Number | 09544818 |
| Lot Number | N/A |
| 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 | 2016-06-29 |