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

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 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the non-reproducible advia centaur cp ahavt reactive result is unknown.This was the only sample affected.The sample was a serum sample in a 7.5 m saarstedt tube and reported to be in good condition.It was initially centrifuged with a hettich centrifuge rotanta 460r for 10min.Based on the information provided, there was a possible issue with the original sample.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the initial false positive result, pre-analytical factors or sample issues cannot be ruled out.Siemens asked the customer to perform a precision run with qc material and the precision was acceptable.Qc was acceptable.The system is performing to specification.No further investigation is required.

Event Description

Customer observed an advia centaur cp hav total (ahavt) result that was initially reactive but non-reactive upon repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the initially reactive advia centaur cp ahavt result.

• Brand Name: ADVIA CENTAUR CP HAV TOTAL (AHAVT) ASSAY
• Type of Device: HEPATITIS A VIRUS (ANTI-HAV) ASSAY
• 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: 6335240
• MDR Text Key: 67659479
• Report Number: 1219913-2017-00023
• 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
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2017
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 77472185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2016
• 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