MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HAV IGM (AHAVM); HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the (b)(6) advia centaur xp hav igm results is unknown.Negative results for three samples from the same patient indicate that the issue is patient specific.Quality control results are in range.Service went on site and performed a total service call.The reagent probe wash stations were not clean.No conclusions can be drawn.Quality control results were in range at the time the samples were tested indicating that the instrument is performing to specification.The limitations section of the instructions for use states: "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A negative test result does not exclude the possibility of exposure to (b)(6) virus.

Event Description

Customer observed a (b)(6) advia centaur hav igm result for three samples from the same patient.A sample from the patient that was (b)(6) on an alternate method for both (b)(6).There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) result.

• Brand Name: ADVIA CENTAUR XP HAV IGM (AHAVM)
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 5101517
• MDR Text Key: 26730024
• Report Number: 1219913-2015-00143
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2017
• Device Model Number: N/A
• Device Catalogue Number: 05004126
• Device Lot Number: 070164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• 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