MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LOCI MODULE (LM); DIMENSION EXL WITH LM

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report a discordant, falsely elevated inorganic phosphorous (phos) patient sample test result was obtained from a dimension exl with loci module (lm) instrument.Siemens connected to the instrument remotely and found that quality control materials processed after the patient sample were elevated.The customer replaced the flex reagent cartridge, recalibrated, ran quality control materials with acceptable results and, following established laboratory practice, repeated the sample.The sample was recentrifuged prior to repeat testing.There are no other reports of discordant phos test results.The cause of the discordant, falsely elevated phos patient sample test result is unknown.The instrument is performing within specifications.No further evaluation of the device is needed.
Event or Problem Description
A discordant, falsely elevated inorganic phosphorous (phos) patient sample test result was obtained from a dimension exl with loci module (lm) instrument.The initial test result was reported to the physician(s).The same sample was repeated on the same instrument where a lower test result was obtained.A corrected test report was issued to the physician(s).There are no reports of patient intervention, or adverse health consequences due to the discordant, falsely elevated inorganic phosphorous test result.

• Brand Name: DIMENSION EXL WITH LOCI MODULE (LM)
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 9831755
• Report Number: 2517506-2020-00101
• Device Sequence Number: 16857812
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 10639337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1