MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® EXL¿ 200 CYCLOSPORINE FLEX® REAGENT CARTRIDGE

Model Number	10285193
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed cyclosporine a (csa) results on the dimension exl system.Hsc has reviewed the information provided by the customer and the instrument data.The issue is consistent with a calibration failure though cause of the failure cannot be determined.The issue was detected by quality control (qc) which was run after several patients resulted below assay range.This issue was resolved by recalibrating the assay.There is no evidence of a product non-conformance of the dimension exl system or the csa assay.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant, falsely depressed cyclosporine a (csa) results were obtained on patients' samples on a dimension exl 200 instrument.The results were not reported to the physician(s).After a new flex was put on-board and a re-calibration was performed, each patient sample was reprocessed on the same date on the instrument and a higher correct result was obtained.There are no known reports of patient intervention due to the discordant, falsely depressed cyclosporine a results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® EXL¿ 200 CYCLOSPORINE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 9795378
• Report Number: 2517506-2020-00085
• Device Sequence Number: 2897230
• Product Code: JJE
• UDI-Device Identifier: 00842768025136
• UDI-Public: 00842768025136
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Expiration Date: 09/25/2020
• Device Model Number: 10285193
• Device Catalogue Number: DF89A SMN 10285193
• Device Lot Number: BA0269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1