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 2018-01-29 for ADVIA CENTAUR XP CALIBRATOR Q N/A 10310296 manufactured by Siemens Healthcare Diagnostics, Inc..
[98537631]
A siemens field service engineer (fse) was sent to the customer site. The fse found the reagent probe 1 alignment was off. The fse performed an alignment on probe 1 with no issues. The customer ran calibrations and quality controls with no issues. After the alignment on probe 1, lot 282 was calibrated with a new shipment of calibrator q lot cq74 and recovery returned to normal. It is unclear whether the probe alignment or the new calibrator resolved the issue. The cause for the discordant advia centaur xp psa results could be due to the probe alignment and/or shipping/handling of the original vials of calibrator q lot cq74. The instrument is performing within specification. No further evaluation of the device is required. The ifu states in the limitations section: "note: do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals. Elevated levels of psa can be observed in patients with nonmalignant diseases. Measurements of psa should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. " mdr 1219913-2018-00005 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[98537632]
Discordant high advia centaur xp psa results were obtained for samples from two patients when changing calibrator lot numbers. The customer swtiched from calibrator lot cq72 from lot cq74 using the same reagent lot 282. The results were higher with lot cq74. The customer also had high recovery with the quality control. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00004 |
| MDR Report Key | 7224238 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-04 |
| Date Added to Maude | 2018-01-29 |
| 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 | 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 CALIBRATOR Q |
| Generic Name | CALIBRATOR Q |
| Product Code | MTF |
| Date Received | 2018-01-29 |
| Model Number | N/A |
| Catalog Number | 10310296 |
| Lot Number | 12631A74 |
| Device Expiration Date | 2018-08-29 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-29 |