MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYVA EMIT AMIKACIN ASSAY; RADIOIMMUNOASSAY, AMIKACIN

Model Number	SYVA EMIT AMIKACIN ASSAY
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely low amikacin result was obtained on a patient sample on an atellica ch 930 system using syva emit amikacin reagent.The erroneous result was reported to the physician(s).After quality controls (qc) recovered out of range the following day, the initial amikacin result was questioned, and the sample was repeated for amikacin and recovered higher.The higher 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 erroneous result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered out of range on the day after the erroneous result was obtained.The assay was recalibrated, after which qc recovered in range.Siemens is investigating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2025-00109 on 14-jul-2025.Additional information (13-oct-2025): siemens has reviewed the instrument data.The issue was resolved with the replacement of the reagent and sample mixers and replacement of the reaction cuvettes as part of routine service troubleshooting and maintenance.The customer has been monitored for reoccurrence by the local team since august and there has been no reported recurrence from the customer.Siemens has received verbal confirmation from the local service the event was resolved with the maintenance performed.The customer is operational, and the reported event is resolved by routine / service part replacement.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: SYVA EMIT AMIKACIN ASSAY
• Common Device Name: RADIOIMMUNOASSAY, AMIKACIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 22496845
• Report Number: 2517506-2025-00109
• Device Sequence Number: 15207130
• Product Code: KLQ
• UDI-Device Identifier: 00842768001543
• UDI-Public: (01)00842768001543(10)S2(17)261108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K822657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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 Model Number: SYVA EMIT AMIKACIN ASSAY
• Device Catalogue Number: 10445383
• Device Lot Number: S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male