MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C)

Model Number	CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C)
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	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer informed siemens that they had used a new wedge for the ca_2c assay and the quality control samples resulted low out of range.Siemens technical application specialist (tas) indicated that the customer recalibrated the ca_2c assay on the same advia chemistry xpt instrument, and the quality control samples recovered within specifications.All patient samples that were falsely low during the initial run were repeated and the results obtained were acceptable to the customer.The cause for the falsely low ca_2c results is unknown.The device is performing within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant falsely low results were obtained on four patient samples on an advia chemistry xpt system when using calcium_2 concentrated assay (ca_2c) reagent lot 424014.The 4 patient samples were repeated again on the same instrument and the results were acceptable.The initial falsely low results for the 4 patients were reported to the physician(s), and not questioned.The corrected repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low results obtained for the ca_2 assay.
Additional Manufacturer Narrative
The initial mdr was filed on 06-jun-2018.Additional information (20-jun-2018): additional information (20-jun-2018): the customer informed siemens that the laboratory policy is to run quality control (qc) samples when a new reagent wedge is used.The laboratory technician failed to run qc when the wedge was replaced and continued to run patient samples causing a shift in patient sample results.Siemens headquarters support center (hsc) informed the customer that the instructions for use (ifu) for the calcium_2c (ca_2c) assay clearly indicates that the assay should be recalibrated when a reagent pack is replaced.The customer recalibrated the assay on the advia chemistry xpt instrument and the qc and patient samples were within acceptable specifications.The hsc specialist concluded that the potential cause of the issue was calibration not being performed on a new ca_2c reagent wedge prior to running the patient samples.

• Brand Name: CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C)
• Common Device Name: CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7579689
• Report Number: 2432235-2018-00239
• Device Sequence Number: 2364702
• Product Code: CJY
• UDI-Device Identifier: 00630414553160
• UDI-Public: 00630414553160
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083386
• 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,Followup
• Report Date (Section B): 06/27/2018

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 Model Number: CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C)
• Device Catalogue Number: 10283344
• Device Lot Number: 424014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1