MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CHEMISTRY CALIBRATOR (CHEM CAL)

Model Number	CHEMISTRY CALIBRATOR (CHEM CAL)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens headquarter support center (hsc) specialist reviewed the information in the complaint.There was no patient diagnosis information associated with these results.There was not enough information provided to determine if the bias or change in recovery is due to change in diagnosis, patient condition, change in calibrator lot, reagent lot or instrument performance.The cause of the discordant, falsely depressed creatinine results is unknown.Advia chemistry calibrator lot 135808 is performing as intended.No further evaluation of the device is required.Mdr 2432235-2018-00151 was filed for the same issue.
Event or Problem Description
Discordant, falsely depressed creatinine (enzymatic method) results were obtained on the advia chemistry enzymatic creatinine_2 (ecre_2) assay.The discordant result was obtained after the assay was calibrated using a new lot of calibrator.The discordant results was not in alignment with previous results of the samples.It is not known if any of the discordant results were reported to physician(s).There are no known reports of patient intervention due to the discordant creatinine results.There are no known reports of a delay in administering treatment or medical intervention to the patients due to the discordant creatinine results.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00152 was filed on 12-apr-2018.Additional information (28-may-2018): additional information was obtained from the siemens customer care center (ccc) specialist.The results obtained with advia chemistry calibrator lot 135808 were part of a comparison study between the results obtained with calibrator lot 135808 and the previous calibrator lot.Quality control materials were in range during the time of the comparison study.The cause of the discordant, falsely depressed creatinine results is unknown.Advia chemistry calibrator lot 135808 is performing as intended.No further evaluation of the device is required.Mdr 2432235-2018-00151_s1 was filed for the same issue.

• Brand Name: CHEMISTRY CALIBRATOR (CHEM CAL)
• Common Device Name: CHEMISTRY CALIBRATOR (CHEM CAL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7426996
• Report Number: 2432235-2018-00152
• Device Sequence Number: 1417669
• Product Code: JIX
• UDI-Device Identifier: 00630414223414
• UDI-Public: 00630414223414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: 04/30/2019
• Device Model Number: CHEMISTRY CALIBRATOR (CHEM CAL)
• Device Lot Number: 135808
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1