MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION; DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE

Model Number	D193440
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer care center determined the root cause of the discordant depressed flagged below assay range malb and cre2 result was operator error and not an instrument issue.Quality control was within laboratory range on the date of testing.No further investigation is required.
Event or Problem Description
A discordant depressed microalbumin (malb) and creatinine urine (cre2) result was obtained on a patient sample on the dimension exl system.A flagged below assay range result was reported to the physician and not questioned.The same sample was repeated on the same instrument and an elevated urine result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed malb and cre2 result.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 6728775
• Report Number: 2517506-2017-00599
• Device Sequence Number: 881700
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: D193440
• Device Catalogue Number: SMN 10639337
• Device Lot Number: DE260144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1