MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG) ASSAY; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reports observation of a discordant elevated total hcg (thcg) result for a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on the same atellica im analyzer and two other atellica im analyzers and lower results were obtained.Calibration and quality controls (qc) were within the expected ranges for thcg.The interpretation of results section of the atellica im total hcg (thcg) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer reports observation of a discordant elevated total hcg (thcg) result for a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on the same atellica im analyzer and two other atellica im analyzers and lower results were obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant, total hcg (thcg) result.

Manufacturer Narrative

Initial mdr 1219913-2023-00300 was filed on 23-nov-2023.Section d8: was this device serviced by a third party? updated to no.Additional information - (b)(6) 2023: sid# (b)(6) discordant result on (b)(6) on (b)(6) 2023 16:52:14 gmt: 29.4 miu/ml repeat on the same system on (b)(6) 2023: <2.0 miu/ml review of reagent trace files: there is no evidence of a hardware issue that is impacting delivery of thcg reagents.Review of sample trace files: there is no evidence of a hardware issue that is impacting delivery of 25ul of sample.

Manufacturer Narrative

Initial mdr 1219913-2023-00300 was filed on 23-nov-2023 and the mdr 1219913-2023-00300 supplemental report 1 was filed on 21-dec-2023.Additional information - 21-dec-2023: the customer reported a falsely elevated discordant patient result on the atellica im total hcg (thcg) assay.On 28-oct-2023, the sample initially resulted in 29.4 miu/ml.The sample was repeated on the same analyzer the following day with a result of <2.0 miu/ml.The sample was also repeated on two other atellica im analyzers with results of <2 miu/ml.The lower repeat results were considered correct.The thcg calibration and quality control (qc) results were within expected ranges on the day of this event.Siemens reviewed the sample and reagent trace files for sid # (b)(6).There was no evidence of a hardware issue that impacted the delivery of thcg lite and solid phase reagents.A review of the sample trace file showed no evidence of a hardware issue that impacted the delivery of 25ul of sample.Based on available information, the cause of the discordant result is consistent with a sample integrity issue.The problem was isolated to just one sample, and the instrument is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG) ASSAY
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 18197953
• MDR Text Key: 328891184
• Report Number: 1219913-2023-00300
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K192790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 41 YR
• Patient Sex: Female