MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. DIMENSION EXL WITH LM; CLINICAL CHEMISTY ANALZYER

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A falsely low sodium (na) result and calcium result was obtained on an emergency room (er) patient sample on a dimension exl with lm instrument.The discordant results were reported and questioned by the physician(s).Quality control (qc) results were within acceptable laboratory ranges.The original sample was submitted for testing via the sample transfer module (stm).Based on result monitors without data, siemens is unable to determine if reagent delivery or foaming issues occurred.The customer observed multiple level sense error (code 750) at the time the original sample was run, the stm aliquot was overflowing, had dried plasma on the outside, and instrument maintenance was not performed.The cause for the discordant result is unknown, however sample integrity issues cannot be ruled out or other maintenance components (example: sample probe tip replacement).The instrument is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely low sodium (na) result and calcium result was obtained on an emergency room (er) patient sample on a dimension exl with lm instrument.The discordant results were reported and questioned by the physician(s).The same patient sample was repeated the on the same dimension exl instrument, resulting higher.The repeat results were reported, as the correct results, to the physician(s).The patient was redrawn on april 17th, run twice on an alternate dimension exl instrument, and results reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low sodium and calcium results.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: CLINICAL CHEMISTY ANALZYER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8604491
• Report Number: 2517506-2019-00188
• Device Sequence Number: 19420572
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/13/2019

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: 04/18/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1