MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)

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	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneously elevated sodium (na) results on two (2) patients obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported erroneously elevated sodium (na) results on two (2) patients were obtained on an atellica ch 930 analyzer.The erroneously elevated results were not reported to the physician(s).The same samples were reprocessed on an alternate atellica ch 930 analyzer.The lower results obtained were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated sodium (na) results.
Additional Manufacturer Narrative
Additional information (20-nov-2024): siemens healthcare diagnostics technical operations concluded the investigation of the event.Technical operations evaluated the information provided by the customer and the available instrument data.Quality control (qc) was within the customer¿s acceptable ranges.The atellica ch integrated multisensor (imt) diluent bottle used by the customer was found to have an improper imt sample dilution due to an insufficient amount of fluid.The customer resolved the issue by replacing the imt diluent bottle with one with a sufficient fluid level.The customer stated the issue was resolved and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Sections b5 and b6 have been updated to provide additional patient data.Section h6 has been updated to reflect the investigation.Initial mdr 2432235-2024-00290 was filed on 07-nov-2024.
Event or Problem Description
The customer reported erroneously elevated sodium (na) results on nine (9) patients were obtained on an atellica ch 930 analyzer.The erroneously elevated results were not reported to the physician(s).The same samples were reprocessed on alternate atellica ch 930 analyzers.The lower results obtained were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated sodium (na) results.

• Brand Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Common Device Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• 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; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20631337
• Report Number: 2432235-2024-00290
• Device Sequence Number: 18178670
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)140011(17)250513(01)00630414596518(10)140011(17)250513
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222438
• 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): 12/02/2024

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: 05/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 140011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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: Unknown