MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CREATININE_2 (CREA_2); ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported a falsely depressed creatinine_2 (crea_2) result on a male patient sample on a atellica ch 930 analyzer.The initial erroneous result was not reported to the physician(s).The sample was repeated on the same atellica ch analyzer.The repeat result was higher than the erroneous result.The repeat result was considered as the correct result by the physician(s).The interpretation of results section of the atellica ch creatinine_2 (crea_2).Instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer reported a falsely depressed creatinine_2 (crea_2) result on a male patient sample on a atellica ch 930 analyzer.The initial erroneous result was not reported to the physician(s).The sample was repeated on the same atellica ch analyzer.The repeat result was higher than the erroneous result.The repeat result was considered as the correct result by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed creatinine_2 result.

Manufacturer Narrative

Siemens filed the initial mdr (b)(4) on jun 30, 2023.Additional information jul 12, 2023: section b5 - the customer reported a falsely depressed creatinine_2 (crea_2) result on a male patient sample on a atellica ch 930 analyzer (s/n (b)(6)) on 06/21/2023 at 10:20.All photometric tests were processed using the same pre-dilution 28.The initial erroneous result was not reported to the physician(s).The sample was repeated on an alternate atellica ch 930 analyzer (s/n (b)(6)), which gave a high result.The repeat result from the alternate instrument was reported to the physician(s).The same sample was repeated again on the original atellica ch analyzer (s/n (b)(6)) and the result was similar to the atellica ch s/n (b)(6) repeat result.This repeat result was considered as the correct result by the physician(s).Return of the patient sample was not required or warranted based upon the results of the technical evaluation.No other samples were impacted or considered discrepant.Correction in section b6: the repeat result obtained on alternate atellica ch (s/n (b)(6)) was not added in the initial mdr.Customer stated that the repeat test on original instrument was done to confirm the result from the alternate atellica ch instrument.Atellica ch (s/n (b)(6)) crea_2 initial result: 0.78 mg/l (erroneous, not reported) alternate atellica ch (s/n (b)(6)) crea_2 repeat result: 1.5 mg/l (reported) atellica ch (s/n (b)(6)) crea_2 repeat result: 1.52 mg/l (correct) a review of the instrument quality control (qc) data showed that all qc was within expected ranges at the time the sample in question was processed.A review of the process error log for atellica ch s/n (b)(6) showed multiple sample specific errors occurring on 06/21/2023 including an error at the time the sample in question was initially processed.The process error log showed there was a sample aspiration error for the sample in question that occurred at the time the dilution probe was making the pre-dilution from the primary sample.A customer service engineer (cse) was dispatched to investigate.The cse replaced the sample mixer (smix) and the reagent mixer (rmix).The cse also adjusted the height of the reaction ring by removing a shim.The parts replaced by the cse is part of normal troubleshooting/maintenance for issues of this nature, therefore, return of the failed parts are not warranted.Based on the information provided and a review of the instrument data, siemens concludes the probable cause of the discrepant patient result for the sample in question was due to a sample aspiration issue that occurred at the time the pre-dilution was being made.All tests utilizing the initial pre-dilution showed falsely low recovery when compared to repeat results using both the initial and alternate instruments.A review of the process error log showed sample aspiration errors for the dilution probe at the time the sample in question was initially processed which further supports a sample specific issue.While siemens cannot conclusively rule out instrument related issues, the most probable cause of the discrepant results is due to sample specific issues such as sample handling and sample integrity.The issue was resolved with normal troubleshooting and the customer is currently fully operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH CREATININE_2 (CREA_2)
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17238020
• MDR Text Key: 318547528
• Report Number: 2432235-2023-00200
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K161494
• 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
• Report Date: 07/26/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 221816
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male