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 2018-10-16 for ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) N/A 10995088 manufactured by Siemens Healthcare Diagnostics, Inc..
[126090821]
All test results are analysed with reagent lot 32689016. The customer noticed variation/bias within ab12 reagent lot 32689016 in the low end of results in quality contol (qc) and with patient results. The reagent is not homogenous, particles/sediment can be seen in the bottom of the reagent readypack from the last two shipments. The same lot has been performing as specified earlier. The customer is calibrating ab12 assay more often and is also running qc as well. The customer received ab12 lot 33437017 for troubleshooting. The low control result on the advia centaur xpt 3 was 13. 9 and the next morning the result was 20. The ranges for ab12 qc results are 11. 7 to 19. 5 for the low control and 45. 3 to 75. 5 for the high control. The reagent seemed to have also a sediment in the bottom of the reagent readypack. Siemens healthcare diagnostics is investigating the cause of the discordant ab12. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[126090822]
Discordant high advia centaur xpt active-b12 (holotranscobalamin) (ab12) results were obtained on a patient sample. The customer observed the reagent is not homogenous, particles/sediment can be seen in the bottom of the reagent readypack for lot 32689016. The initial testing was on (b)(6) 2018 and the repeat testing was on (b)(6) 2018. The results were not reported to the physician. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the ab12 discordant results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00258 |
| MDR Report Key | 7970421 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-16 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-09-14 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2018-10-16 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) |
| Generic Name | AB12 IMMUNOASSAY |
| Product Code | CDD |
| Date Received | 2018-10-16 |
| Model Number | N/A |
| Catalog Number | 10995088 |
| Lot Number | 32689016 |
| Device Expiration Date | 2019-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-16 |