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 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

The initial sample was recovered and checked by the customer and found to contain fibrin.After removing the fibrin, the sample was reprocessed and a positive result was obtained.Siemens healthcare diagnostics is investigating this issue.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states: "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).There are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents.".

Event Description

A false negative atellica im total hcg (thcg) result was obtained on a patient sample.This result was reported and questioned by the physician.The patient was retested with a different sample, and the result was positive.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

Siemens filed the initial mdr on june 21, 2019.Corrected data: patient sample 1 date tested was incorrectly recorded in the initial mdr (section b6) as on (b)(6) 2019 and should have been on (b)(6) 2019.Additional data from 08/14/2019: patient (b)(6), female, 37 years old, underwent thcg testing on (b)(6) 2019.Sample was processed on atellica im ih00576 and generated a result of 2.0miu/ml.This result was released to the doctor who questioned the result.On (b)(6) 2019, another sample from the same patient was further tested (b)(6).This sample was processed in a supporting laboratory and a result 1000miu/ml was obtained and after dilution (x200) 4742 miu/ml.The primary sample was recovered (b)(6) and checked by the customer to contain fibrin / clot.After removing the clot, the sample was reprocessed on (b)(6) 2019 and yielded a result 1000miu/ml.This issue is a non-reproducible false low thcg result due to fibrin.No product performance issue has been identified with atellica total hcg assay.The system clot detection is based on a change in pressure and there is a possibility that the clot could impede the pipetting but not cause a large enough pressure change to trigger the error.No product problem has been identified.Investigation complete.No further evaluation of the device is required.

• 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
• MDR Report Key: 8721676
• MDR Text Key: 151751186
• Report Number: 1219913-2019-00117
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (y/n): N
• PMA/PMN Number: K172322
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 82755304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR