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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Siemens is reviewing data from a small precision study performed at the customer site and has requested additional information.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: "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.This kit is not intended for any use other than assessment of pregnancy status." (b)(4).

Event Description

A customer observed a discordant high atellica im total hcg (thcg) patient result.The discordant result was not provided to the physician.Retesting was performed on the same day on the sample using 2 other instruments.The retest results were lower and believed to be correct.One of the lower retest results was reported to the physician.Quality control and calibration results were within specifications.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant thcg result.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00240 on 09/11/2020.Additional information 09/11/2020: the customer provided patient information, however the information provided did not include confirmation of gender or clinical history/diagnosis.No other information was provided to siemens, including results of the small precision study expected from the customer site.Additional information 09/17/2020: siemens reviewed calibration and quality control (qc) results and found all results to be acceptable on (b)(6), as this instrument produced the discordant results.Siemens service engineer was inspected instrument (b)(6).Reagent probes 2 & 3 were replaced, pipettor was realigned, wash probes replaced and latch assay motor was replaced.The problem has been resolved for the customer by service and recalibration of the assay.System verification indicates acceptable performance after the service visit.No other issues have been reported by the customer since the service visit.The customer is operational.Siemen's investigation is complete and no product problem was identified.The result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Type of Device: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10520406
• MDR Text Key: 238580301
• Report Number: 1219913-2020-00240
• 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: 10/07/2020

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: 12/06/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1