MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930

Model Number ATELLICA CH 930

Device Problem Low Test Results (2458)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) to report that falsely depressed lactate_3 (lac_3) results were obtained on an atellica ch 930 analyzer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse replaced and aligned the sample mixer and repaired and aligned the reagent 1 (r1) arm.Next, the cse ran successful auto checks and the customer processed quality controls, which recovered acceptably.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Falsely depressed lactate_3 (lac_3) results were reportedly obtained on two patient samples on the atellica ch 930 analyzer.These results were reported to the physician(s).The samples were processed on an alternate atellica ch 930 analyzer and recovered higher than the erroneous results.The repeat results were reported to the physician(s), as the correct results.There are no known reports of adverse health consequences due to the event.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2024-00086 on (b)(6) 2024.Additional information ((b)(6) 2024): a siemens customer service engineer (cse) performed additional actions which included replacing and aligning the r1 (reagent 1 probe) and diluent probe and replacing the level sense and pressure transducer.Siemens evaluated reagent, instrument, and sample data and ruled out reagent issues based on acceptable quality control (qc) recovery.Additionally, siemens observed that the calibration performed which was used to generate the low qc controls and discordant patients had a signal separation between the two levels of calibrator which was lower than the previous calibrations.Siemens concluded that this calibration potentially contributed to the falsely depressed lactate_3 (lac_3) results, which was resolved by the customer performing a new lot calibration, as recommended by siemens.Section b6 was updated to provide the updated patient results which siemens found when assessing the sample data.The investigation findings and investigation conclusions codes in h6 were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CH 930
• Type of Device: ATELLICA CH 930
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 19217570
• MDR Text Key: 341574975
• Report Number: 2432235-2024-00086
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: 00630414002163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA CH 930
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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
• Patient Sex: Male