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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2018

Event Type  malfunction  

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 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
• Type of Device: CALIBRATOR Q
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 7224238
• MDR Text Key: 98537631
• Report Number: 1219913-2018-00004
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00630414202921
• UDI-Public: 00630414202921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1