MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930; 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 04/12/2023

Event Type  malfunction  

Event Description

Low-level quality control (qc) and falsely depressed creatinine_2 (crea_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer, s/n: cm03271.The initial results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate instrument.The repeat results were higher than the initial erroneous results and matched patient history.The repeat results were reported, as the correct results, to the physician(s).The customer confirmed that there was no harm to the patients and no delay in testing due to the event.There are no known reports of patient intervention or adverse health consequences due to low-level qc and falsely depressed crea_2 results.

Manufacturer Narrative

The united states customer contacted siemens customer care center and reported that low-level quality control (qc) and falsely depressed creatinine_2 (crea_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.Due to the low-level qc, the customer inspected the reagent pack and found that the reagent pack had plastic coverings in the cap where only foil is supposed to be.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse found a reagent bottle with different colors and materials for seal.During total service action (tsa), the cse replaced the reagent pack with the bottle and performed qc and calibration.Siemens continues to investigate.

Manufacturer Narrative

Initial mdr 2432235-2023-00117 was filed on may 24, 2023.Additional information ¿ aug 28, 2023: the customer reported the initial issue as discordant (low) atellica creatinine_2 (crea_2) results.Based on the limited information provided, the shift (low) in atellica ch crea_2 quality control (qc) and multiple discordant (low) patient results are consistent with the customer service engineer's (cse) observation of an improperly sealed crea_2 reagent pack.A repeat of the same samples yielded the expected results.Quality control (qc), calibration, and patient results performed on the new crea_2 reagent bottle indicate acceptable performance, and no issues were reported with other patient samples.Based on the results of the investigation, the return of the patient sample is not warranted.The customer is operational.The complaint-related information has been reviewed, and the information provided does not indicate a reagent lot or method issue.The shift in quality control (qc) (low) observed by the customer was generated by a damaged reagent pack.The customer's findings cannot be replicated without a returned product showing the physical damage to the cap observed by the customer.However, the expected results were generated with the replacement of the pack.The manufacturing records and retained samples for lot 221631 were reviewed by the product's physical manufacturer.The retained samples showed no evidence of damage.Additionally, the manufacturing records indicated that the product was dispensed in june 2022.Over 15,000 reagent packs were produced at the time of dispense.The cap component lots used were common to over 30 product lots.There was no evidence of an elevated reject count for pack quality at the packaging stage.The manufacturing quality control testing record indicates that the product was performing as intended.The physical manufacturer's review and investigation show no evidence of a potential product, process deviation, or systemic issue that could lead to the physical defect.There is no evidence of a potential product issue.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH 930
• 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.; 55 diamond road; registration # 8020890; crumlin co. antrim bt29 4qy ; UK
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16991146
• MDR Text Key: 315827895
• Report Number: 2432235-2023-00117
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161494
• 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,Followup
• Report Date: 09/06/2023

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: 08/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 221631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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