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

Catalog Number S600 SMN 10445058

Device Problem Low Test Results (2458)

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

Event Date 07/08/2023

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed potassium (k) patient sample result obtained on a dimension exl 200 system.Siemens is investigating the event.

Event Description

A discordant falsely depressed potassium (k) patient sample result was obtained on a dimension exl 200 system.It is unknown if the falsely depressed result was reported to the physician(s).The same sample was reprocessed on the same dimension exl 200 system.Higher results, considered correct, were obtained.One of the higher reprocessed results was reported as the correct result to the physician(s).There are no known reports of patient intervention and adverse health consequences due to the falsely depressed potassium (k) result.

Manufacturer Narrative

Additional information (17-aug-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Hsc noticed the customer processed the affected sample using an expired sensor lot.The issue was resolved after a new sensor lot was loaded on the dimension exl 200 system.Hsc concluded the investigation of the event is consistent with the nonstandard use of the sensor lot.A potential product issue was not identified.The instrument is operational."date of event" for the falsely depressed potassium (k) patient sample result is unknown.Section b3 is updated conservatively to 08-jul-2023 since the affected sensor lot expired on 08-jul-2023.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00176 was filed on 11-aug-2023.

• Brand Name: DIMENSION®
• Type of Device: 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: 17514359
• MDR Text Key: 321106207
• Report Number: 2517506-2023-00176
• Device Sequence Number: 1
• Product Code: CEM
• 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: 09/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 3AC802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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