MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-20 for ADVIA CENTAUR XP FSH N/A 01360521 manufactured by Siemens Healthcare Diagnostics, Inc..
[19588119]
Customer performed a method comparison with 75 samples between advia centaur xp fsh reagent lots 033186 and 033188. The samples tested were across the range of the assay (0. 3 to 200 miu/ml). An average positive bias of 17% was observed by the customer with reagent lot 033188 compared to reagent lot 033186. There were no reports that treatment was altered or prescribed based on these results. There are no reports of adverse health consequences based on these results.
Patient Sequence No: 1, Text Type: D, B5
[19824045]
Siemens performed an internal study comparing advia centaur fsh reagent lot 033186 and 033188. Quality control material results were all within range. Patient samples did not show the consistent bias observed by the customer. The customer gathered additional data and determined that the overall patient bias that they were observing is 9%. The root cause of the initial positive bias with advia centaur xp fsh reagent lot 033188 cannot be determined based on the information available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00312 |
| MDR Report Key | 3531209 |
| Report Source | 05,06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-16 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2014-03-31 |
| 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 FSH |
| Generic Name | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE |
| Product Code | CGJ |
| Date Received | 2013-12-20 |
| Model Number | N/A |
| Catalog Number | 01360521 |
| Lot Number | 033188 |
| Device Expiration Date | 2014-05-26 |
| 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 | 2013-12-20 |