MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY; HBSAG CONFIRMATORY IMMUNOASSAY

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problem Venipuncture (2129)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

Customer observed a (b)(6) advia centaur xp (b)(6) result that confirmed reactive with the advia centaur (b)(4) confirmatory assay.The physician requested a re-draw of the patient samples.There are no reports that treatment was altered or prescribed or adverse health consequences based on the discordant reactive results.

Manufacturer Narrative

The cause of the (b)(6) advia centaur xp (b)(6) confirmed by the advia centaur xp (b)(4) conf test is unknown.The customer noted that the advia centaur xp (b)(4) and the advia centaur xp (b)(4) confirmatory test were not calibrated on the same day as instructed in the instructions for use.No conclusions can be drawn.The customer cannot rule out preanalytical error.The sample is no longer available.The customer declined service and feels that the issue was specific to this sample.The limitations section of the instructions for use states:" for diagnostic purposes and to differentiate between acute and chronic hbv infection, the detection of (b)(6) should be correlated with patient clinical information and other hbv serological markers.It is recognized that presently available methods for detection of hepatitis b surface antigen may not detect all potentially infected individuals.A (b)(6) test result or invalid confirmatory result does not exclude the possibility of exposure to or infection with (b)(6).".

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY
• Type of Device: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 4224015
• MDR Text Key: 21724501
• Report Number: 1219913-2014-00261
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 03393818
• Device Lot Number: 31196
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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