MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-06 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[85011903]
Siemens requested the patient sample and information on the diagnosis and treatment of the patient. Additional information and the sample were not provided. Siemens service went on site and inspected and tested the advia centaur xp in diagnostics. The system checks were good and within limits. The acid and base dispense properly. A precision study of afp, ca 15-3 and cea showed no issues. A precision study of the sample in question was performed and no issues were observed. Qc passed within limits. Siemens reviewed the customer's calibrations and control values and did not observe any issues. The root cause of the elevated result with this one sample cannot be determined. The sample was not tested on any other lot of reagent. The expected results section of the instructions for use states: "in this study, 98. 4% of the apparently healthy subjects had afp values less than 8. 1 ng/ml. " the table shows that 12 apparently healthy subjects had values between 8. 1 ng/ml and 20. 0 ng/ml. The warning in the intended use section of the instructions 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. " the interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " based on the information available, advia centaur afp lot 188 is performing as intended. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[85011904]
Customer observed a reproducibly, elevated advia centaur xp alpha-fetoprotein (afp) result on one patient sample compared to historical results and an alternate method. The physician questioned the result since historically, the result was lower. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00190 |
| MDR Report Key | 6845673 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-08-14 |
| Date Mfgr Received | 2017-08-21 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2017-09-06 |
| 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 | 2017-09-06 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 188 |
| Device Expiration Date | 2018-06-06 |
| 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 | 2017-09-06 |