MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed creatinine (cre2) result was obtained on a patient sample on the dimension exl with lm instrument.Quality control (qc) was acceptable at the time of sample processing.A siemens customer service engineer (cse) was dispatched to the customer¿s site.After performing preventative maintenance, the cse replaced sample and reagent 1 (r1) drains, reagent 2 (r2) drain, and sample and reagent probes.The cse also made an adjustment to reduce the height of the front cuvette film guide.Subsequently, siemens verified the instrument¿s performance and ran a system check, which recovered acceptably.The customer verified qc and the instrument¿s performance is being monitored.The cause of the falsely depressed cre2 result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A falsely depressed creatinine (cre2) result was obtained on a patient sample on the dimension exl with lm instrument.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the same instrument.The repeat result recovered higher than the erroneous result.The repeat result was reported to the physician(s) as the correct result.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed cre2 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00064 on 12-feb-2024.Additional information (12-mar-2024): in addition to the service actions mentioned in the initial report, a siemens customer service engineer (cse) replaced the reagent 2 drain assembly and reagent 3 (r3) probe, verified cuvette temperature, cleaned all cuvette windows, aligned photometer, and deactivated the reagent management system (rms) as a precaution to eliminate potential issues in the reagent module system.Next, the cse activated the rms, ran quality control 10 times, precision study on patient sample, which recovered acceptably.Siemens reviewed the instrument data and concluded that the intermittent carryover contamination between tests potentially contributed to the falsely depressed creatinine (cre2) result.The investigation conclusion in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 18686747
• Report Number: 2517506-2024-00064
• Device Sequence Number: 12361345
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K944093
• 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
• Report Date (Section B): 03/27/2024

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 Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown