MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® CHEMISTRY I CALIBRATOR

Catalog Number	DC18C SMN 10716280
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens headquarters support center (hsc) completed the investigation of the discordant, falsely depressed creatinine (cre2) results.Hsc has reviewed the instrument data and the information provided.The siemens technical application specialist and customer care center discovered that for the old cre2 calibration, the customer had hydrated calibrator vials with 1 milliliter of water versus the recommended 2 milliliters of distilled water.Per the advisement of siemen's personal, the customer hydrated a new set of calibrator vials with 2 milliliters of distilled water for the new calibration.Quality control values had decreased by half after initial cre2 calibration and then recovered after recalibration.The issue was resolved by recalibration of the cre2 assay with properly hydrated calibrators.The cause of the event was use error due to improperly hydrating calibrator lot, 9ad058.No product non-conformance was identified with the assay or analyzer.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant falsely depressed creatinine (cre2) results were obtained on multiple patient samples on a dimension exl 200 instrument.The discordant results were reported to the physician(s) and questioned.The same samples were reprocessed on the same instrument and higher results were obtained.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed creatinine (cre2) results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CHEMISTRY I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8745043
• Report Number: 2517506-2019-00253
• Device Sequence Number: 1488706
• Product Code: JIT
• UDI-Device Identifier: 00630414948492
• UDI-Public: 00630414948492
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K860021
• 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): 06/28/2019

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 Expiration Date: 01/01/2020
• Device Catalogue Number: DC18C SMN 10716280
• Device Lot Number: 9AD058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1