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

Model Number CHEMISTRY CALIBRATOR (CHEM CAL)

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered outside of range at the time of the event.The customer has stopped processing calcium tests on their advia chemistry xpt systems.Siemens is investigating the issue.

Event Description

Discordant, falsely elevated calcium_2 concentrated (ca_2c) patient results were obtained on an advia chemistry xpt system following calibration with chemistry calibrator (chem cal) lot 993624.The initial results were reported to the physician(s).The samples were not repeated, and patients were sent to the hospital to have a new blood sample drawn to measure free calcium.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca_2c results.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2020-00494 on 29-dec-2020.Correction (08-jan-2021): quality controls (qc) did not recover out of range when the customer tested the patient samples for calcium.However, there was still a positive bias on calcium qc.The customer has not stopped processing calcium samples on their advia chemistry xpt systems.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2020-00494 on 29-dec-2020.Siemens filed the first supplemental mdr 2432235-2020-00494_s1 on 03-feb-2021.Additional information (29-mar-2021): siemens conducted an internal investigation into this issue, but the data was inconclusive to pre-confirm a potential product issue related to biases observed with calcium when using the advia chemistry calibrator lot 993624.Additional testing is still being performed by siemens.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2020-00494 on 29-dec-2020.Siemens filed the first supplemental mdr 2432235-2020-00494_s1 on 03-feb-2021.Siemens filed the second supplemental mdr 2432235-2020-00494_s2 on 22-apr-2021.Additional information (07-dec-2021): siemens reviewed the calcium_2 (ca_2) quality control (qc) data provided using the previous lot of chemistry calibrator (chem cal) (lot 453025b) and compared the recovery to qc data run using chem cal lot 993624.After switching to chem cal lot 993624, the ca_2 qc recovery showed a slight positive bias.However, the ca_2 qc still recovered within range and did not exceed the manufacturer's limit of ±5%.The chem cal lot 993624 is performing as expected.Siemens also reviewed the data analysis performed by the customer for the ca_2 patient moving mean.The data shows a bias in ca_2 results during the time chem cal lot 993624 was in use.However, no specific patient data or specific samples were provided for siemens to review.Siemens is unable to investigate whether the bias in ca_2 results is due to chem cal lot 993624 or if there were other contributing factors to the event.The shift in ca_2 qc recovery observed is due to changes with the factor value assignments for the ca_2 method assigned to the new mega lot (production lot) of chem cal.As a result, customers may experience a shift in recovery with the new mega lot 993624, as well as all future lots of chem cal lot 993626 that are produced using this same mega lot of calibrator.This shift is within expected performance of the qc manufacturer ranges; however, customers using user defined ranges (peer ranges) may see shifts outside of their user defined ranges.Customers should adjust their qc ranges accordingly to the new performance standard.Siemens performed an additional internal investigation to ensure accuracy of qc and patient samples while using chem cal lot 993626.Multiple chem cal vials were tested at different time points after vial hydration for multiple chem cal lots with no significant difference in recovery across all analytes assigned to the calibrator.Vial-to-vial variability was also tested across multiple chem cal lots with no significant difference in recovery across all analytes assigned to the calibrator.Customer bulletins have been released to customers describing the typical recovery biases across all available commercial chem cal lots when tested against the master lot.All calibrator lots were released within the manufacturing specifications.There is no evidence of a product nonconformance related to any in-date chem cal lots.The customer is currently fully operational.The calibrator is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CHEMISTRY CALIBRATOR (CHEM CAL)
• Type of Device: CHEMISTRY CALIBRATOR (CHEM CAL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): THERMO FISHER SCIENTIFIC; registration # 3010939897; 46500 kato road; fremont CA 94538
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 11091156
• MDR Text Key: 250340016
• Report Number: 2432235-2020-00494
• Device Sequence Number: 1
• Product Code: JIX
• UDI-Device Identifier: 00630414223414
• UDI-Public: 00630414223414
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K050374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CHEMISTRY CALIBRATOR (CHEM CAL)
• Device Catalogue Number: 10312279
• Device Lot Number: 993624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1