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 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The type of blood collection tube used was lithium heparinize plasma tube from bd.The sample was not tested with multi-diluent 11 with the atellica im (b)(6) assay.The patient was not vaccinated for (b)(6).The customer had a patient sample that recovered positive (198.17 iu/ml) with the atellica im (b)(6) assay on (b)(6) 2019 but was negative on two alternate methods.When the sample was tested on another atellica im system, it recovered positive (~200 iu/ml).The sample was also (b)(6) reactive (>1000 index).The data provided by the customer showed the sample recovered 339.98 miu/ml on s/n/ (b)(4) with atellica im (b)(6) lot 109 on (b)(6) 2019 and 301.53 miu/ml on s/n (b)(4) with atellica im (b)(6) lot 117 on (b)(6) 2019.Siemens reviewed the calibration data provided 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 no sample that can be sent to siemens for evaluation.The clinical sensitivity and specificity section of the atellica im (b)(6) surface antigen 2 ((b)(6)) 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.This one false positive result does not indicate a product problem with atellica im (b)(6) lots 109 and 117.The cause of the false positive result seen by the customer when using atellica im (b)(6) lots 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 instrument is performing within specifications.No further evaluation of the device is required.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 1219913-2019-00224, 1219913-2019-00225 and 1219913-2019-00226 were filed for the same event.

Event Description

A discordant positive atellica im (b)(6) surface antigen 2 ((b)(6)) result was obtained for a patient sample.The (b)(6) result for the patient sample was positive.The customer tested the patient sample on two alternate methods and the results were negative.The patient sample was run on another atellica im system by the siemens' field application specialist (fas) and the result was positive.The patient sample was run on both atellica im systems on another day and the results were positive.The positive result was not reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the (b)(6) results.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole,, MA 02032 ; 5086604603
• MDR Report Key: 9287829
• MDR Text Key: 220623926
• Report Number: 1219913-2019-00227
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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