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 2017-07-21 for ADVIA CENTAUR XP AFP ASSAY N/A 10309980 manufactured by Siemens Healthcare Diagnostics, Inc..
[80804813]
Siemens requested a list of medications that the patient is receiving and also asked if the sample is available for testing. The information and the sample are not available. Root cause of the difference in results between the advia centaur afp and the alternate method with this one sample cannot be determined. The warning in the intended use section of the advia centaur afp instruction for use states: "the concentration of afp in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the afp assay used. Values obtained with different afp assay methods cannot be used interchangeably. " additionally, the warning in the intended use section of the advia centaur afp instruction for use states: "use afp results only as part of the overall clinical evaluation of a patient. Do not use afp results as the only criterion for diagnosis. " based on the available information advia centaur afp is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[80804814]
Customer observed an elevated advia centaur xp alpha-fetoprotein (afp) result compared to an alternate method and the clinical picture. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00159 |
| MDR Report Key | 6734490 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-07-04 |
| Device Manufacturer Date | 2016-11-22 |
| Date Added to Maude | 2017-07-21 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP AFP ASSAY |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2017-07-21 |
| Model Number | N/A |
| Catalog Number | 10309980 |
| Lot Number | 20819186 |
| Device Expiration Date | 2018-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-21 |