MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG); TOTAL HCG,

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Per the interpretation of results section of the instructions for use: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." per the limitations section of the instructions for use: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory." "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts." siemens investigation is complete.The customer reported a high discordant thcg patient result on 8/9/2019.The high result was questioned so the patient was redrawn and retested.The new draw resulted negative for thcg.No sample volume was remaining from the 8/9/2019 for repeat.No issues were reported with controls or other patient samples.This issue only affected the one draw from this patient.Siemens has reviewed this escalation and ruled out the assay as the cause of the discordant result.Siemens reviewed all the acquired log files from the atellica im analyzer.The logs did not contain any errors or abnormalities on the day of this incident that could help explain the elevated result.Based on the log review siemens cannot definitively determine the cause of this discrepant result., but cannot rule out sample integrity, and/or other preanalytical variables as contributing factors.However, quality controls samples were in range and no issues were noted with other patient samples, indicating that the instrument and reagents were performing acceptably.A systemic product non-conformance has not been identified.No further evaluation of the device is required.

Event Description

A falsely elevated atellica im thcg result was obtained on (b)(6) 2019 using reagent lot 306 (kit lot 54207306).The physician questioned the result.The patient was redrawn and retested over the next two days.Both retest results were lower, as expected.A corrected report was issued based on the retest results.Although the customer indicated the prescribing of medication (isotretinoin) was delayed approximately one week because of this event, there was no report of adverse health consequences due to the initial discordant total hcg result.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Type of Device: TOTAL HCG,
• 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5086608576
• MDR Report Key: 9050368
• MDR Text Key: 214799807
• Report Number: 1219913-2019-00168
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K172322
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 54207306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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