MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); AHBS2 IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." mdr 1219913-2020-00003 (sample id 461090404031) was filed for the same event.

Event Description

Discordant positive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results were obtained for two samples from the same patient.The testing was performed in (b)(6) for the first sample and the second sample was tested in (b)(6).A third sample was tested in (b)(6) and the results were negative.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the ahbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00004 on january 08, 2020.January 09, 2020 additional information: the customer had a sample ((b)(6) ) that recovered nonreactive (<3.1 miu/ml) with atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot 121 but previous samples from the patient had recovered reactive ((b)(6) in (b)(6).6 miu/ml with lot 109; (b)(6) in (b)(6).3 miu/ml with lot 117) with the atellica im anti-hbs2 assay.The nonreactive (negative) result was confirmed by two other alternate methods.All three samples were atellica im hbsii, ahbct, chiv, and ahcv nonreactive.When the customer retested all three samples they recovered nonreactive (<3.1 miu/ml) with atellica im anti-hbs2 lot 121.Siemens reviewed the customer's calibration and control data and there is no evidence of a problem.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient is taking.There is insufficient sample to send to siemens for further evaluation.The clinical sensitivity and specificity section of the atellica im ahbs2 instructions for use (ifu) (10995277, revision 03, 2019-04) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false positive results can be expected for this assay.The false positive results with samples from this one patient do not indicate a product problem with atellica im anti-hbs2 lots 109 and 117.The cause of the false positive results seen by the customer with samples from this one patient when using atellica im anti-hbs2 lot 109 and 117 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is awaiting further information from the customer.Mdr 1219913-2020-00003 supplemental report 1 was filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00004 on january 08, 2020.Siemens filed the mdr 1219913-2020-00004 supplemental report on january 31, 2020.May 15, 2020 additional information: siemens sourced patients samples from asia, europe, and the united states and while some samples did perform similar to the customer's samples with the atellica im ahbs2 assay, the number of samples does not indicate the atellica im ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).A review of smart remote services (srs) field data by siemens for the atellica im ahbs2 lots showed lots 109 and 117 had a similar distribution of nonreactive/reactive results to other lots.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.The device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00003 supplemental report 2 was filed for the same event.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9565221
• MDR Text Key: 193925875
• Report Number: 1219913-2020-00004
• 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,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR