MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

Model Number	DIMENSION EXL 200
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that falsely depressed tacrolimus (tac) results were obtained on three patient samples on the dimension exl 200 instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and confirmed that the temperatures of the constant temperature layer and reagent storage were within range and that no abnormalities were found in the optical system and photometer in the pxqc test.Then, the cse cleaned the drains and quartz windows, replaced and adjusted the sampler, reagent 1 (r1), and reagent 2 (r2) probe tips, and ran system check and sample absorbance (sabs) test, which detected air bubbles in the cuvette.As a result, the cse replaced the r1 ultrasonics unit, ran pxqc tests, system check and quality control (qc), which recovered acceptably.The cause of the falsely depressed tac results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely depressed tacrolimus (tac) results were obtained on three patient samples on the dimension exl 200 instrument.The erroneous results were not reported to the physician(s).The samples were repeated several times on the original instrument; with the exception of the second repeat result for the sample identified as 00620112704, the repeat results recovered higher than the erroneous results.For the sample identified as 00620112704, the second repeat result recovered lower and was considered erroneous.The higher repeat results were considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tac results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00186 on 16-jul-2024.Corrected data (08-aug-2024): the initial report portrayed the following sequence of results for the sample identified as (b)(6): sample identifier: (b)(6), initial result: <0.00, 1st repeat result: 7.88, 2nd repeat result: 1.86, 3rd repeat result: 7.32.Through log files, siemens determined the following sequence of results for the sample identified as (b)(6): sample identifier: (b)(6), initial result: 1.86 ng/ml, 1st repeat result: 0.00 ng/ml, 2nd repeat result: 7.88 ng/ml, 3rd repeat result: 7.32 ng/ml.Additional information (08-aug-2024): in addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) verified service method tests.Siemens reviewed the instrument data and ruled out reagent issues as quality control (qc) and calibration recovered within acceptable ranges on the day of the event.The service activities performed by the cse, described in initial report and this report, returned the instrument to normal operations.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL 200
• Common Device Name: DIMENSION EXL 200
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19754194
• Report Number: 2517506-2024-00186
• Device Sequence Number: 8987825
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130276
• 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): 08/23/2024

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 200
• Device Catalogue Number: 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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