MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® ENZYMATIC CARBONATE FLEX® REAGENT CARTRIDGE

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	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneously elevated enzymatic carbonate (eco2) results on four patient samples on a dimension exl with lm system.The erroneously elevated patient results were not reported to the physician(s).The same samples were reprocessed on an alternate dimension exl with lm system.The reprocessed results recovered lower and were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated enzymatic carbonate (eco2) patient results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the erroneously elevated enzymatic carbonate (eco2) results on four patient samples obtained on a dimension exl with lm system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data and the information provided by the customer.Calibration was acceptable and quality control recovered within the customer¿s expected ranges.The review of the instrument data indicated no sample integrity issues.A siemens customer service engineer (cse) was dispatched to the customer¿s site and replaced the sampler, probe tips and performed the reagent 1 (r1) alignments, which were part of standard troubleshooting procedures.Hsc concluded that r1 alignments, might cause foam and produce erroneous results.Following this standard troubleshooting procedure, the issue appears to be resolved although a specific cause for this event was not identified.A product problem has not been identified.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® ENZYMATIC CARBONATE FLEX® REAGENT CARTRIDGE
• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19730021
• Report Number: 2517506-2024-00184
• Device Sequence Number: 8032728
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: (01)00842768005374(10)FA5071(17)20250312
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010206
• 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
• Report Date (Section B): 07/12/2024

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: 03/12/2025
• Device Model Number: N/A
• Device Catalogue Number: DF137 SMN 10444972
• Device Lot Number: FA5071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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