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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding falsely depressed sodium (na) results obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.

Event Description

Three (3) falsely depressed sodium (na) patient sample results were obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed patient results were not reported to the physician.The same samples were reprocessed 16-march-2024 on the same dimension® exl¿ 200 integrated chemistry system.Higher results obtained were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed sodium (na) results.

Manufacturer Narrative

Additional information (29-april-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available data logs.The customer stated they observed a sample probe clot error on the day of the event.The sample tip was replaced and aligned the next day.The customer stated the issue was resolved and no other discordant results were reported.The cause of the event is consistent with sample probe tip with clot error.A potential product issue was not identified.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 2517506-2024-00110 was filed on 27-march-2024.

• Brand Name: DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR
• Type of Device: 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: 18987149
• MDR Text Key: 338718546
• Report Number: 2517506-2024-00110
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 3LD826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1