MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-07-19 for ADVIA CENTAUR XPT VB12 ASSAY N/A 10309970 manufactured by Siemens Healthcare Diagnostics, Inc..
[49957306]
The cause for the discordant vb12 results is unknown. The customer was running samples during the weekend (as not everyone is yet trained on the system). The customer was also not sure if the samples could be frozen. Therefore, one sample was placed in the freezer and the other sample in the refrigerator. Siemens healthcare diagnostics is investigating. The ifu states in the specimen collection and handling section: "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
[49957307]
Discordant advia centaur xpt vb12 (vitamin b12) results were obtained on samples from two patients. The customer received two samples from each patient. One sample was placed in the freezer and the second sample was placed in the refrigerator on saturday (b)(6) 2016. The samples were tested on monday, (b)(6) /2016. The results from the frozen samples were reported to the physician. The physician questioned the results. The refrigerated samples were then run and the results were reported to the physician. The results of these samples matched the medical situation of the patients. The frozen samples were repeated after one day in the refrigerator and the results were similar to the refrigerated samples. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the vb12 discordant results.
Patient Sequence No: 1, Text Type: D, B5
[55240029]
Siemens filed the initial mdr 1219913-2016-00123 on july 19, 2016. On 08/19/2016 additional information: the cause for the discordant vb12 results appears to be a sample handling issue. The results from the frozen sample are different than the refrigerated sample. The customer has agreed not to freeze the sample tubes in the future, but to keep them in the refrigerator until testing. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00123 |
| MDR Report Key | 5803934 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-19 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2016-08-19 |
| Device Manufacturer Date | 2015-12-10 |
| Date Added to Maude | 2016-07-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. 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 XPT VB12 ASSAY |
| Generic Name | VB12 IMMUNOASSAY |
| Product Code | CDD |
| Date Received | 2016-07-19 |
| Model Number | N/A |
| Catalog Number | 10309970 |
| Lot Number | 229 |
| Device Expiration Date | 2016-11-10 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |