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

Model Number CHEMISTRY CALIBRATOR (CHEM CAL)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarter support center (hsc) specialist reviewed the information in the complaint.There was not enough information provided to determine if the results were a comparison of calibrator lot 135808 to a previous calibrator lot or if the results were a comparison between two calibrations of the same calibrator lot.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 result is unknown.Advia chemistry calibrator lot 135808 is performing as intended.No further evaluation of the device is required.Mdr 2432235-2018-00152 was filed for the same issue.

Event Description

A discordant, falsely depressed creatinine (enzymatic method) result was obtained on the advia chemistry enzymatic creatinine_2 (ecre_2) assay.The discordant result was obtained with a new lot of advia chemistry calibrator.The discordant result was not in alignment with the previous result from this sample.It is not known if the discordant result was reported to physician(s).There are no known reports of patient intervention due to the discordant creatinine result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the discordant creatinine result.

Manufacturer Narrative

The initial mdr 2432235-2018-00151 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 result is unknown.Advia chemistry calibrator lot 135808 is performing as intended.No further evaluation of the device is required.Mdr 2432235-2018-00152_s1 was filed for the same issue.

• Brand Name: CHEMISTRY CALIBRATOR (CHEM CAL)
• Type of Device: CHEMISTRY CALIBRATOR (CHEM CAL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7426998
• MDR Text Key: 105881215
• Report Number: 2432235-2018-00151
• Device Sequence Number: 1
• Product Code: JIX
• UDI-Device Identifier: 00630414223414
• UDI-Public: 00630414223414
• Combination Product (y/n): N
• PMA/PMN Number: K050374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1