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 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) patient results compared to (b)(6) results with a fresh reagent readypack is unknown.The customer's quality control results were acceptable at the time of the event.Siemens is investigating this incident and has requested the patient samples for investigation.

Event Description

(b)(6) results were obtained by the customer and on two patient samples.The (b)(6) results were considered discordant compared to the patient clinical pictures, and (b)(6) results when the same samples were tested with a fresh reagent readypack of the same reagent lot.There was no report of patient treatment being altered or adverse health consequences due to the discordant (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00203 on 11/03/2016 for (b)(6) advia centaur cp hav total (ahavt) results on two patient samples.On 01/25/2017 - additional information: the cause for the (b)(6) advia centaur cp hav total (ahavt) results is unknown.The two patient samples were provided for additional testing.These samples were tested with three lots of advia centaur cp ahavt reagent (lots 073181, 073182, and 073183), and the results were (b)(6).The reagent readypack in question was not provided for additional testing.Siemens was unable to confirm the customer's observation of (b)(6) results.No conclusion can be drawn the instrument is performing within specification.No further investigation is required.

• 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6076656
• MDR Text Key: 59133741
• Report Number: 1219913-2016-00203
• 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
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• 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