MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CALIBRATOR Q

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ADVIA CENTAUR XP CALIBRATOR Q
• Common Device Name: CALIBRATOR Q
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7224238
• Report Number: 1219913-2018-00004
• Device Sequence Number: 16373138
• Product Code: MTF
• UDI-Device Identifier: 00630414202921
• UDI-Public: 00630414202921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310296
• Device Lot Number: 12631A74
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1