MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL); ELECTRODE, ION SPECIFIC, POTASSIUM

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	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a falsely depressed sodium (na) result on one patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument.The repeat result recovered higher than the erroneous result.The repeat result was considered as correct result.There are no known reports of patient interventions or adverse health consequences due to the falsely depressed sodium (na) result.
Additional Manufacturer Narrative
An outside the united states customer obtained a falsely depressed sodium (na) result on one patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument.The repeat result recovered higher than the erroneous result.The repeat result was considered as correct result.The interpretation of results section of the atellica ch a-lyte integrated multisensor (imt na k cl) 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".Siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00192 on jun 27, 2023.Siemens filed mdr 2432235-2023-00192 supplemental 1 on jul 19, 2023.Additional information jul 20, 2023: an outside the united states customer obtained a falsely depressed sodium (na) result on one patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument.The repeat result recovered higher than the erroneous result.The repeat result was considered as correct result.Based on siemens investigation on the available information, the probable cause of falsely low sodium (na) result for sample id (b)(6) is most likely sample specific due to poor pre-analytical sample quality and the presence of gel, fibrin, microclots, and/or the presence of cellular debris including red cells, white cells, and platelets in the sample that the impacted proper sample aspiration for the sample predilution.The instrument is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.
Additional Manufacturer Narrative
Siemens filed, the initial mdr on jun 27, 2023.Additional information: jun 28, 2023, the customer provided additional information.After the initial mdr was filed.The calibration and quality controls (qc) were valid at the time sample was run.The sample id of the patient is sid (b)(6).Section d4: updated lot number#: 120013 and expiration date 28-nov-2023.Section d8: was this device serviced by a third party? updated to no.Section h4: device manufacture date updated as 28-nov-20223.Siemens continues to investigate.

• Brand Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive; newark DE 19714 6101
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17207374
• Report Number: 2432235-2023-00192
• Device Sequence Number: 6798856
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K161954
• 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,Followup
• Report Date (Section B): 08/14/2023

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: 11/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 120013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023; 07/20/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/19/2023; 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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: Unknown