MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY; AHBS IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report discordant, (b)(6) atellica im anti-hbs2 (ahbs2) result.The customer's quality control results were acceptable when testing was performed.Siemens healthcare diagnostics is investigating.

Event Description

A (b)(6) atellica im anti-hbs2 (ahbs2) result was obtained by the customer on a patient and reported to the physician(s).The (b)(6) ahbs2 result was considered discordant compared to a (b)(6) ahbs2 new sample result run on a new reagent lot.The original sample was retested on the new reagent lot and the ahbs2 result was (b)(6).The (b)(6) anti-hbs retest result was reported to the physician(s) as the corrected result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant atellica im anti-hbs2 (ahbs2) result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00090 report on 09-mar-2020 for a false positive atellica im anti-hbs2 (ahbs2) result.20-mar-2020 - additional information: the customer was not able to provide the patient's medical status or a list of medications/supplements.There is no patient sample available for further evaluation by siemens.The clinical sensitivity and specificity section of the atellica im anti-hepatitis b surface antigen 2 (ahbs2) instructions for use (ifu) ((b)(4), revision 04, 2019-07) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%.A review of internal data indicates atellica im ahbs2 lots 123 and 125 are performing as intended.The cause of the discrepant results seen by the customer when using atellica im ahbs2 lots 123 and 125 could not be determined, however siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.On 10-apr-2020 - additional information: siemens has reviewed the event data and has concluded the incident investigation.Customer support feedback regarding the incident investigation was deemed acceptable.In summary, the cause of the discordant false positive atellica im anti-hbs2 (ahbs2) result observed by the customer when using atellica im ahbs2 lot 123 is unknown, however siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The assay is performing within specification.No further evaluation of the device is required.Section h6 results and conclusion code was updated to reflect the additional information.

• Brand Name: ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9808210
• MDR Text Key: 193382612
• Report Number: 1219913-2020-00090
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 123
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1