MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2); AHBS2 IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer went on site and completed contamination testing, wash dispense and aspirate testing, cleaned the wash block, completed dispense tests to visually observe proper dispensing, checked the acid and base dispense and adjusted volume to 3 ml, verified proper alignment of reagent probe 3 and adjusted cuvette bottom settings to 2 steps.On another visit, decontamination of the acid and base was performed using cleaning solution.New reservoirs, gaskets and bulk acid and base bottles were installed.Background testing and dark counts testing were performed.The ahbs2 assay was calibrated and qc testing was performed.Calibration and qc passed.Siemens continues to investigate.The interpretation of results section of the instructions for use states: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".

Event Description

Customer observed an advia centaur xp anti-hbs2 (ahbs2) result that was elevated and (b)(6) and did not match the clinical picture of the patient.The physician questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ahbs2 result.

Manufacturer Narrative

Mdr 1219913-2019-00056 was filed reporting an elevated advia centaur xp anti-hbs2 result that did not match the clinical picture of the patient.Additional information - may 23, 2019 while the issue was corrected by performing the acid and base decontamination, the cause of the contamination was not determined.The system is now performing as designed.Root cause of the imprecision with advia centaur xp ahbs2 lot 102 was an issue resolved with normal instrument troubleshooting.Based on the investigation, no product problem was identified.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8554623
• MDR Text Key: 161590894
• Report Number: 1219913-2019-00056
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1