MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA IM TOTAL HCG; THCG ASSAY

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

The customer observed an initial depressed patient sample result measured on the atellica im 1600 total hcg (thcg) assay, that was discordant with the repeat results from the same sample when remeasured on an alternate atellica im analyzer.The result was reported to the physician who did not question the result.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant atellica im thcg result.

Manufacturer Narrative

An outside the united states customer observed an initial depressed patient sample result measured on the atellica im 1600 total hcg(thcg) assay, that was discordant with the repeat results from the same sample when remeasured on an alternate atellica im analyzer.Three levels of quality control biorad - liquichek immunoassay plus control - lot 85300, were processed and their results were within the limits of laboratory acceptance.Routine samples were processed in the same pack.No issues were observed with the reagent pack or pre-analytical handling.The interpretation of results section of the atellica im thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00258 on aug 30, 2022.Additional information - sep 08, 2022 and sep 28, 2022 an outside the united states customer reported a discordant patient result on atellica im 1600 total hcg (thcg) reagent, lot 338.On aug 11, 2022, the patient sample was initially tested on atellica im sn# (b)(6) with a thcg result of 2.7 miu/ml.The same sample was repeated on two other atellica im analyzers and the thcg results were 5.2 and 5.15 miu/ml.All results are clinically negative but the difference between the initial vs.Repeat results is outside the laboratory's acceptance limit.Biorad qc lot 85300 recovered within range on the day of this event.The customer stated that there were no issues identified in the review of thcg level 1 qc performance on atellica im 1600 sn# (b)(6).This issue appears to have been isolated to just the one sample (sid (b)(6).Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Level 1 mean= 9.052 sd= 0.60 cv= 6.64%; level 2 mean= 26.7 sd= 2.36 cv= 8.83%; level 3 mean= 411.2 sd= 42.8 cv= 10.4%; while there is insufficient information to determine the cause of this single discordant thcg patient result, siemens cannot rule out pre-analytical factors or a sample handling issue.The customer is operational.No non-conformance product issue was identified.Update to section d4: the expiration date of the product did not appear in the initial mdr.The expiration date sep 12, 2022 has been added to section d4.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM TOTAL HCG
• Type of Device: THCG ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15321948
• MDR Text Key: 301077680
• Report Number: 1219913-2022-00258
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414006703
• UDI-Public: 00630414006703
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K172322
• 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
• Report Date: 09/30/2022

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: 09/12/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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: 21 YR
• Patient Sex: Female