MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG ASSAY; TOTAL HCG IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, falsely elevated atellica im total hcg (thcg) result obtained on a patient sample.A siemens customer service engineer (cse) was sent to the customer site for system evaluation.The cse performed a total service visit and replaced the sample probe air pump and reagent probes 1 & 3.Siemens is investigating.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
A falsely elevated (positive) atellica im total hcg (thcg) assay result was obtained by the customer on a patient sample and reported to the physician.The physician questioned the elevated (positive) result compared to an lower (negative) alternate qualitative test method result.The customer performed repeat thcg testing, resulting lower (negative).A second sample was drawn and the thcg result was lower (negative).The lower (negative) thcg result was reported to the physician as the correct result.There was no report of patient treatment being prescribed or altered, or adverse health consequences due to the discordant, falsely elevated atellica im thcg result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00444 initial report on 16-sep-2021 for a discordant, falsely elevated nonrepeatable result on the atellica im total hcg (thcg) assay.15-oct-2021 - additional information: a united states customer reported a falsely elevated nonrepeatable result on the atellica im total hcg (thcg) assay.The physician questioned this result because a qualitative hcg test was also performed and was reported as negative.The customer repeated the same sample and tested a new sample, all resulting lower.The lower thcg results were clinically expected.Quality control was within range on the day of testing the samples.Both samples from this patient were serum and pre-analytical variables cannot be ruled out.The system auto-check and instrument (sn (b)(6)) data for (b)(6) 2021 were reviewed and considered acceptable.A customer service engineer (cse) performed a total service visit on instrument (sn (b)(6)) which included replacing the sample probe air pump and replacing reagent probes 1 and 3.Replacement of the parts by the cse are considered normal troubleshooting for an issue of this nature.Based on the information provided the potential cause is unknown.A potential product issue was not identified.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: ATELLICA IM TOTAL HCG ASSAY
• Common Device Name: TOTAL HCG 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; east walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 12481180
• Report Number: 1219913-2021-00444
• Device Sequence Number: 19801722
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female