MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH TACROLIMUS (TACR); ENZYME IMMUNOASSAY, TACROLIMUS

Model Number	N/A
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Discordant elevated tacrolimus (tacr) results were obtained on samples from two patients on an atellica ch 930 instrument (s/n(b)(6)).The initial results were reported to the physician(s), who questioned the results.The samples were repeated on the same atellica ch 930 instrument.The repeat results were lower than the initial results.Corrected report(s) were issued.The patients were both organ transplant recipients.There are no known reports adverse health consequences due to the discordant elevated tacrolimus (tacr) results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report an above assay range result for tacrolimus (tacr) on a patient sample when processed on an atellica ch 930 instrument (s/n (b(6)) with repeat (diluted) results lower and within the assay range.Siemens has reviewed the instrument data and service documentation.The quality control (qc) and calibration were within customer limits at the time of the event.Service was dispatched and the saline manifold value along with the dilution probe arm was replaced.The qc and calibration were out of limits after that service event so service returned and replaced the sample and dilution mixers.The qc and calibration came within published limits after this service event.The issue was resolved with routine maintenance and part replacement.Replacement of the parts are considered normal troubleshooting or maintenance for issues of this nature; therefore return of the parts is not warranted.The cause of the issue was with the function of the sample aspiration, dilution and delivery system.Exact identification of the specific part is not possible with the available data however the issue was resolved with routine maintenance.The interpretation of results section of the instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." the instrument is performing within specifications.No further evaluation of the device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2023-00275 on december 14, 2023.December 14, 2023 correction: this a correction to section h6 of the initial mdr.The initial mdr had the incorrect code for the medical device problem section.The correct code is 2457.Section h6 has been updated with the information.This is a correction to section h10 of the initial mdr.Section be h10 stated ¿ a united states (us) customer contacted a siemens customer care center to report an above assay range result for tacrolimus (tacr) on a patient sample when processed on an atellica ch 930 instrument (s/n (b)(6) ) with repeat (diluted) results lower and within the assay range.¿ the correct statement is ¿a united states (us) customer contacted a siemens customer care center to report discordant elevated tacrolimus (tacr) results were obtained on samples from two patients on an atellica ch 930 instrument (s/n (b)(6) ).¿.

• Brand Name: ATELLICA CH TACROLIMUS (TACR)
• Common Device Name: ENZYME IMMUNOASSAY, TACROLIMUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 18325509
• Report Number: 2517506-2023-00275
• Device Sequence Number: 7359023
• Product Code: MLM
• UDI-Device Identifier: 00630414238340
• UDI-Public: 00630414238340
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097542
• Device Lot Number: 130218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male