MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION QUIKLYTE INTEGRATED MULTISENSOR

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	04/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained two (2) erroneously depressed sodium (na) patient sample results on a dimension exl 200 system.The erroneously depressed results were reported to the physician(s), and the results were questioned.It is unknown if the same samples or new samples drawn from the same patients were reprocessed on the original dimension exl 200 system and on an alternate dimension exl with lm system.The reprocessed and/or redrawn results obtained were higher, matched patient history and were considered correct.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) patient results.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed sodium(na) patient sample results obtained on a dimension exl 200 system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (30-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc observed that the calibration was acceptable and the dilution check passed.Quality control (qc) recovery was within the customer¿s acceptable ranges, indicating that the sodium (na) assay was performing acceptably.The issue was resolved by replacing the sensor with a new sensor from the same lot as per the standard laboratory maintenance schedule.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00136 was filed on (b)(6) 2024.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION QUIKLYTE INTEGRATED MULTISENSOR
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19219879
• Report Number: 2517506-2024-00136
• Device Sequence Number: 8194740
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K112999
• 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
• Report Date (Section B): 06/19/2024

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: 07/06/2024
• Device Model Number: N/A
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4AD802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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