MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1300 AHBS2; AHBS2 IMMUNOASSAY

Model Number N/A

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant atellica im 1300 (b)(6) result compared to the clinical picture is unknown.Siemens is investigating and has requested the sample.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

The customer reported a discordant positive patient result using the atellica im 1300 anti-(b)(6) surface antigen ((b)(6)) compared to the clinical picture.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im 1300 (b)(6) result.

Manufacturer Narrative

Siemens filed initial mdr (b)(4) on (b)(6)2019.Additional information from (b)(6)2020: siemens tested the sample provided by the customer and was able to duplicate the reactive result with atellica im ahbs2 lot 117 (complaint lot), but the sample was nonreactive with atellica im ahbs2 lot 105 and 121.Siemens investigation results are as follows: lot 105 result: 1.22 miu/ml, lot 117 result: 88.2 miu/ml, lot 121 result: 0.61 miu/ml, the volume of the sample provided was insufficient to determine why the sample was reactive with lot 117 and nonreactive with other lots.Siemens is in process of sourcing other samples to continue investigation.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2019-00242 on 11/22/2019 and mdr 1219913-2019-00242 supplemental report 1 on april 21, 2020.Additional information 05/15/2020: investigation complete.The customer observed a patient sample result that was reactive (69 miu/ml) with atellica im anti-hbs2 (ahbs2) lot 117 but nonreactive with the enzygnost anti-hbs assay.The sample was also hbsii reactive (> 1000 index), hbct reactive (>8 index), and has a high viral load (> 8.5 log ui/ml).The patient has chronic hepatitis b (a case of fetal-maternal transmission).The customer was not able to provide a list of medications/supplements the patient is taking.Siemens tested the sample provided by the customer and was able to duplicate the reactive result with atellica im ahbs2 lot 117 but the sample was nonreactive with other atellica im ahbs2 lots.The volume of the sample provided was insufficient to determine why the sample was reactive with lot 117 and nonreactive with other lots.Siemens sourced patients samples from asia, europe, and the united states but was not able to find any samples that perform similar to the customer's sample with the atellica im ahbs2 assay.A review of smart remote services (srs) field data from europe for atellica im ahbs2 lots was reviewed and showed lot 117 had a similar distribution of nonreactive/reactive results to other lots.The clinical sensitivity and specificity section of the atellica im ahbs2 ifu (10995277, revision 04, 2019-07) 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.This one false positive patient sample does not indicate a product problem with atellica im ahbs2 lot 117.A review of siemens' internal data and field data indicates atellica im ahbs2 lot 117 is performing as intended.The specific cause of the reactive result observed by the customer with this one sample when using atellica im ahbs2 lot 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 customer is operational.No further investigation required.The device, method, result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.

• Brand Name: ATELLICA IM 1300 AHBS2
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9365799
• MDR Text Key: 219763116
• Report Number: 1219913-2019-00242
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 66240117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 03/24/2020; 05/15/2020
• Supplement Dates FDA Received: 04/21/2020; 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR