MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY; ENZYME IMMUNOASSAY, GENTAMICIN

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated syva® emit® 2000 gentamicin plus assay result was obtained on a patient sample on a viva-proe system (sn: (b)(6)).The erroneous result was reported to the physician(s), and the result was questioned.The patient was taking gentamicin, but the result was flagged by the clinical team and believed to be pharmacokinetically implausible in the light of treatment given and subsequent result.The sample was insufficient in volume to perform repeat testing.True value was not provided.There are no known reports of patient intervention or adverse health consequences due to the discordant syva® emit® 2000 gentamicin plus assay result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated syva® emit® 2000 gentamicin plus assay result that was obtained on a patient sample on a viva-proe system.Quality controls (qcs) and calibration recovered within ranges on the day of the event.The syva® emit® 2000 gentamicin plus assay instructions for use (ifu) states: "results of this test should always be interpreted in conjunction with the patient¿s medical history, clinical presentation and other findings." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00089 with the fda on 05-mar-2024.Additional information 04-apr-2024: siemens investigation has concluded.The initial issue was discordant syva® emit® 2000 gentamicin plus assay results obtained on three patient samples on a viva-proe system (sn: (b)(6).The customer service engineer (cse) inspected the system and performed hub adjustment.After adjustment the system met the instrument qualification specifications, which returned the system to normal operation.These service actions are considered normal troubleshooting for issues of this nature.Probable cause can not be determined.Performance was improved by optical hardware adjustments, however sample handling may have contributed to the discrepant results.The viva-proe system syva® emit® 2000 gentamicin plus assay lot r2 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and conclusion codes were updated.

• Brand Name: SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY
• Common Device Name: ENZYME IMMUNOASSAY, GENTAMICIN
• 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: karen confort ; 333 coney street; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 18835823
• Report Number: 2517506-2024-00089
• Device Sequence Number: 7458209
• Product Code: LCD
• UDI-Device Identifier: 00842768001086
• UDI-Public: 00842768001086
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• PMA/510(K) Number: K962519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 04/04/2024

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: 09/08/2024
• Device Model Number: N/A
• Device Catalogue Number: 10445333
• Device Lot Number: R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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