MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP HAV TOTAL (AHAVT); TOTAL ANTIBODY TO HEPATITIS A VIRUS

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 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) total results is unknown.Siemens requested the alt and crp results for the patients but they are not available.Siemens also requested the numeric (b)(6) results but these have not yet been provided.Siemens asked if the samples are available for testing but has not yet received a response.Qc is within range indicating the instrument is performing within specifications.

Event Description

Customer observed four advia centaur xp (b)(6) results that were slightly (b)(6).The (b)(6) results were (b)(6) and the patients had not been vaccinated.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) results.

Manufacturer Narrative

Siemens filed mdr 1219913-2016-00141 on (b)(6) 2016 reporting four advia centaur cp (b)(6) total results that were slightly (b)(6).The (b)(6) results were (b)(6) and the patients had not been vaccinated.October 4, 2016 siemens was notified that the samples are not available for testing.There is no additional information available regarding the patients or the samples.A siemens customer service engineer went on site and performed a total service visit including a precision check.All results were acceptable.The cause for the discordant advia centaur cp (b)(6) total results is unknown.No further investigation is required.

• Brand Name: ADVIA CENTAUR CP HAV TOTAL (AHAVT)
• Type of Device: TOTAL ANTIBODY TO HEPATITIS A VIRUS
• 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: 5871192
• MDR Text Key: 51929867
• Report Number: 1219913-2016-00141
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2017
• Device Model Number: N/A
• Device Catalogue Number: 05498862
• Device Lot Number: 073181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1