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	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely depressed calcium (ca) result, flagged with below assay range, was obtained on a patient sample on a dimension exl with lm instrument.The falsely depressed result was not reported to the physician(s).The patient sample was repeated on the original instrument, recovering higher.The repeat result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca result.
Additional Manufacturer Narrative
An outside of the united states (us) customer contacted a siemens customer care center and reported that a falsely depressed calcium (ca) result was obtained on a patient sample on a dimension exl with lm instrument.Quality controls (qcs) were acceptable on the day of event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse checked sample probe and reagent 2 (r2) probe alignment and replaced the sample and r2 metering pumps.The cause of the falsely depressed ca result is unknown.Siemens is investing the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2022-00228 on 09-sep-2022.Additional information (20-sep-2022): siemens further investigated the incident and concluded that this event is not a reagent lot or method issue.In addition to the activities listed in the initial report, in subsequent visits, the siemens customer service engineer (cse) replaced sample probe, sample ultrasonics transducer, and sample drain.The cse also performed alignments and cleaned the reagent 2 (r2) drain.Siemens further investigated the issue and stated that the issue was resolved by replacing the sample drain.The component code and investigation conclusions code in section h6 were updated based on 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: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 15391583
• Report Number: 2517506-2022-00228
• Device Sequence Number: 11988302
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/21/2022

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: 08/17/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2015
• 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