MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SYPHILIS (SYPH); SYPHILIS ASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) results is unknown.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.The ifu states in the limitations section: a nonreactive test result does not exclude the possibility of exposure to or infection with (b)(6) antibodies may be undetectable in some stages of the infection and in some clinical conditions.Assay performance characteristics have not been established for the atellica im syph assay used in conjunction with other manufacturers' assays for specific (b)(6) serological markers." mdr 1219913-2019-00133 (initial result) and mdr 1219913-2019-00135 (repeat result on s/n (b)(4)) were filed for the same event.

Event Description

A discordant (b)(6) atellica im syphilis (syph) result was obtained for a patient sample.The patient sample was repeated on both atellica im systems on a different date and the results were (b)(6).The initial detection of treponemal antibodies at the emergency service was (b)(6).Testing on an alternate method yielded (b)(6) results.Confirmatory testing was performed.The tpha result was indeterminate and the fta result was (b)(6).The rpr result was (b)(6).Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant atellica im syphilis (syph) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00134 on july 19, 2019.09/19/2019 additional information: the patient sample was received by siemens and tested with atellica im syphilis reagent lot: 128060.The sample was also processed with a scantabodies nabt (non-specific antibody blocking tube) tube to test for non-specific interferents in a particular sample.Results: date: on (b)(6) 2019, patient id: reagent lot: neat result (index), (b)(6), 128060, 0.65 (negative).Date: on (b)(6) 2019, (b)(6): rgt lot: 128060, nabt result (index), interpretation, rep 1, 0.66, negative, rep 2, 0.69, negative, rep 3, 0.64, negative.The index of the sample did not change significantly.Based on the information provided and the results of the investigation, siemens is unable to rule out a sample specific issue.The atellica im syphilis ifu (10995422_en rev.03, 2017-12) states "the results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.A nonreactive test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions." based on the information provided a product problem was not identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00133 supplemental report 1 (initial result) and mdr 1219913-2019-00135 supplemental report 1 (repeat result on s/n: (b)(6) were filed for the same event.

• Brand Name: ATELLICA IM SYPHILIS (SYPH)
• Type of Device: SYPHILIS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8808420
• MDR Text Key: 166539774
• Report Number: 1219913-2019-00134
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00630414599885
• UDI-Public: 00630414599885
• Combination Product (y/n): N
• PMA/PMN Number: K112343
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995675
• Device Lot Number: 63204060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR