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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely depressed digoxin (dgn) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial atellica ch 930 analyzer.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
A falsely depressed digoxin (dgn) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial atellica ch 930 analyzer.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed digoxin (dgn) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00282 on november 06, 2023.A united states (us) customer contacted a siemens customer care center to report a falsely depressed digoxin (dgn) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial atellica ch 930 analyzer.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).November 08, 2023 additional information: the customer experienced quality control out of range for the atellica ch digoxin (dgn).The siemens technical application specialist (tas) calibrated the assay and ran the quality control.The quality control was acceptable.Siemens healthcare diagnostics continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00282 on november 06, 2023.Siemens filed the mdr 1219913-2023-00282 supplemental report 1 on december 04, 2023.A united states (us) customer contacted a siemens customer care center to report a falsely depressed digoxin (dgn) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial atellica ch 930 analyzer.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).January 18, 2024 additional information: siemens reviewed the digoxin instrument data from atellica ch s/n (b)(6) between december 2023 to january 2024.Siemens was unable to identify the discordant patient samples as a sample identifier was not provided.Multiple attempts were made to gather more information to investigate, however, the requested information required to investigate this incident was not made available to siemens.Therefore, further investigation is not possible.The cause of the discordant digoxin results is unknown.The instrument is operational.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH DIGOXIN (DGN)
• Common Device Name: ENZYME IMMUNOASSAY, DIGOXIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 18072875
• Report Number: 1219913-2023-00282
• Device Sequence Number: 7594345
• Product Code: KXT
• UDI-Device Identifier: 00630414595863
• UDI-Public: 00630414595863
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011302
• 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,Followup
• Report Date (Section B): 02/14/2024

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: 01/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097526
• Device Lot Number: 130021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 01/18/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/04/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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: Unknown