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 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ahbs2 results is unknown.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 1219913-2018-00277, mdr 1219913-2018-00278, mdr 1219913-2018-00279, mdr 1219913-2018-00280, mdr 1219913-2018-00282, and mdr 1219913-2018-00283 were filed for the same event.

Event Description

Discordant (b)(6) atellica im anti-hepatitis b surface antigen 2 (ahbs2) results were obtained for a patient sample from the same run on the same readypack on the same day upon retest.The patient sample was tested previously on a different readypack and the result was (b)(6).The patient sample was retested again on two different readypacks and the results were (b)(6).The customer sent out the patient samples to be tested with an alternate instrument.The results were (b)(6).Hbt (heterophilic blocking tube) testing was performed on the patient sample and the result was (b)(6).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 1219913-2018-00281 on november 27, 2018.11/30/2018 additional information: all the samples that tested positive for ahbs2 were hbsag positive samples that were over 1000 with atellica im platform.The patients are under treatment.It is unknown what medicine is being taken.The patient samples are not available for further testing and investigation.Siemens healthcare diagnostics is awaiting further information.Mdr 1219913-2018-00277 supplemental report 1, mdr 1219913-2018-00278 supplemental report 1, mdr 1219913-2018-00279 supplemental report 1, mdr 1219913-2018-00280 supplemental report 1, mdr 1219913-2018-00282 supplemental report 1, and mdr 1219913-2018-00283 supplemental report 1 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2018-00281 on november 27, 2018.Siemens filed the mdr 1219913-2018-00281 supplemental report 1 on december 17, 2018.02/05/2019 additional information: the customer had samples that were repeatedly reactive with the atellica im anti-hepatitis b surface antigen 2 (ahbs2) reagent lot 087 but nonreactive when tested with an alternate method.All of the samples were reactive (>1000 index) with the atellica im hepatitis b surface antigen (hbs) assay.One of the samples was treated with a heterophilic blocking tube (hbt) and after treatment the result was nonreactive with atellica im ahbs2 reagent lot 087.Although the result changed after hbt treatment there are no antibodies in the architecture of the atellica im ahbs2 assay, so heterophilic antibodies are not causing the reactive atellica im ahbs2 results.The patients are undergoing treatment but it is unknown which medicine they are taking.The samples are not available for additional testing.While there is insufficient information to determine the cause of the reactive results, siemens cannot rule out pre-analytical factors or sample issue.Based on the investigation, no product problem was identified.Mdr 1219913-2018-00277 supplemental report 2, mdr 1219913-2018-00278 supplemental report 2, mdr 1219913-2018-00279 supplemental report 2, mdr 1219913-2018-00280 supplemental report 2, mdr 1219913-2018-00282 supplemental report 2, and mdr 1219913-2018-00283 supplemental report 2 were 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: 8107629
• MDR Text Key: 129439775
• Report Number: 1219913-2018-00281
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 63041087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1