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

Model Number	ATELLICA CH CHEMISTRY CALIBRATOR (CHEM CAL)
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed low calcium_2 (ca_2) results on multiple patient samples on an atellica ch 930 analyzer.The depressed results were reported to the physician(s), who questioned the results.The customer recalibrated the assay and repeated six patient samples.The repeat results recovered higher.The repeat results were reported, as the correct results, to the physician(s).While twelve other patient samples recovered low, these samples were not available for repeat testing.The results for these twelve samples were included in this report in an abundance of caution.There are no known reports of patient intervention or adverse health consequences due to the low ca_2 patient results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported low calcium_2 (ca_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The customer processed patient samples while the quality control (qc) was out of range.Siemens informed the customer that qc recovered out of range the day before the event; however, it was not repeated prior to processing the affected samples.The customer resolved the issue by recalibrating the assay and running qc, which recovered within acceptable ranges.Therefore, a use error contributed to the event.The analyzer is performing within specifications.No further evaluation of the analyzer is needed.
Additional Manufacturer Narrative
Siemens filed initial mdr on 28-apr-2022.Additional information (18-may-2022): siemens further investigated the issue and determined that there is no reagent or method issue.Siemens determined that the customer performed a pack calibration on 04-apr-2022 prior to running patient samples and quality controls (qc).Qc recovered out of range low using the pack calibration.Prior to repeating the samples in question, the customer performed a new pack calibration on 04-apr-2022 and all levels of qc recovered within acceptable ranges.No further issue with calcium_2 (ca_2) was observed after recalibration.Siemens determined that the pack calibration potentially contributed to the discordant ca_2 results as the slope calibration coefficient recovered significantly higher than the other calibrations.Inconsistent calibrator handling and reconstitution potentially contributed to the discordant ca_2 patient results.The high c1 (slope) coefficient resulted in falsely low ca_2 recovery for both quality control (qc) and patient results.Section d1, section d2, the model #, catalog #, lot #, expiration date, and unique identifier # in section d4, section g1 contact office - manufacturing site, g4 pma/510(k), and h8 were updated based on the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CH CHEMISTRY CALIBRATOR (CHEM CAL)
• Common Device Name: ATELLICA CH CHEMISTRY CALIBRATOR (CHEM CAL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): THERMO FISHER SCIENTIFIC; 8365 valley pike; registration # 1181121; middletown VA 22645
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 14242065
• Report Number: 2432235-2022-00121
• Device Sequence Number: 4791349
• Product Code: JIX
• UDI-Device Identifier: 00630414597492
• UDI-Public: 00630414597492
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022
• 2 Devices were Involved in the Event: 1 2

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: 04/30/2023
• Device Model Number: ATELLICA CH CHEMISTRY CALIBRATOR (CHEM CAL)
• Device Catalogue Number: 11099411
• Device Lot Number: 228150C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown