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 2018-12-27 for ADVIA CENTAUR XP AFP ASSAY N/A 10309980 manufactured by Siemens Healthcare Diagnostics, Inc..
[132503650]
The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient results is unknown. The customer's assay calibration and quality controls (qc) were acceptable. The customer informed siemens that initial afp concentrations were not above the assay measurement range. For example: the sample from (b)(6) had an initial afp result of 7. 5 ug/l, when pre-diluted with negative serum pool and tested the next day, the results were 1. 7 ug/l (1:10), 14. 5 ug/l (1:20), 49. 8 (1:200) and eventually yielding a result of > 1000 ug/l. Siemens is investigating the event. The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " mdr 1219913-2018-00309 was filed for an elevated afp result on the same patient on a different day.
Patient Sequence No: 1, Text Type: N, H10
[132503651]
Falsely elevated advia centaur xp alpha-fetoprotein (afp) results were observed on a patient sample and questioned by the physician. The patient was transferred to another hospital for a liver transplantation in (b)(6) 2018, however the afp measured at this hospital was normal. The patient was discharged with no abnormality detected. There are no reports of adverse health consequences due to the discordant advia centaur xp afp results. Mdr 1219913-2018-00309 was filed for an elevated afp result on the same patient on a different day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00308 |
| MDR Report Key | 8199928 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-27 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-12-27 |
| 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 | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP AFP ASSAY |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN |
| Product Code | LOJ |
| Date Received | 2018-12-27 |
| Model Number | N/A |
| Catalog Number | 10309980 |
| Lot Number | 041199 |
| Device Expiration Date | 2018-05-15 |
| 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 | 2018-12-27 |