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

Model Number ATELLICA CH 930 MODULE

Device Problems Low Test Results (2458); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center.The initial result was questioned by the physician so the sample was repeated on an alternate system.When using the alternate system, the customer could not run qc immediately as the system indicated that the calibration was expired when the run was attempted.The customer later noticed that the calibration was actually not due for another few hours.The pack was calibrated on the alternate system where the qc was acceptable and the results were higher.Another attempt was then made to rerun the sample on the original system and a higher correct result was also obtained.Siemens is investigating the issue.

Event Description

One discordant, falsely depressed acetaminophen (acet) result was obtained using atellica ch 930 analyzer.The initial result was reported and was questioned by the physician(s).A first repeat result using an alternate atellica ch 930 analyzer (s/n (b)(4)) was considered correct and reported to the physician(s).A second repeat result using the original instrument was also considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed acet results.

Manufacturer Narrative

Siemens filed initial mdr on 5-nov-2019 and supplemental mdr 2432235-2019-00387-s1 on 7-jan-2020.Additional information (24-feb-2020): siemens healthcare diagnostics investigated this issue regarding the atellica ch 930 analyzers.Siemens determined that auto-rerun or auto-dilution results may generate a result of zero (0) for quantitative assays or negative for qualitative assays if a well of the reagent pack is not calibrated.If the atellica ch 930 analyzer runs out of reagent in one well of a reagent pack while processing an auto-rerun or auto-dilution, the system attempts to use the next well of a reagent pack, however if the next well of the pack does not have a valid calibration, the auto-rerun or auto-dilution will be reported as zero (0) for quantitative assays or negative for qualitative assays instead of 'error'.An urgent medical device correction (umdc) asw20-03.A.Us was sent to us customers and an urgent field safety notice (ufsn) asw20-03.A.Ous was sent to outside the us (ous) customers in february of 2020.The umdc and ufsn explain the behavior described above (as issue#2 in the umdc/ufsn) and requests customers to ensure all reagent packs have a valid calibration (all wells) before running samples.This information is available on the screen calibration > calibration overview.Customers are referred to the atellica solution online help 1.20 instructions, "viewing assay reagent calibration order status".The umdc and ufsn delineate that software is being developed to resolve the behavior.To date, there are no allegations of injury due to this behavior.

Manufacturer Narrative

The initial mdr(b)(4) was filed on (b)(6)2019.Additional information (11-dec-2019): siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc found that the calibration was acceptable at the time the original result was processed.Quality control (qc) results were found within the ranges established by the customer at the time of the event.Hsc reviewed the instrument filterdata to compare the discordant result to its repeats as well as surrounding results.Hsc observed alignment with the results and no atypical performance.Hsc found that the results were generated from different wells of the same acetaminophen (acet) reagent pack.Hsc could not confirm reagent contamination as qc results processed prior to the discordant result were within ranges.Siemens research and development (r&d) software team performed an additional investigation of the issue.R&d found that the atellica software reported a value of 0 umol/l while the initial result from the same sample is greater than the measuring interval and that the calibration expired prior to the processing of the auto-dilution.No error flag ("calibration required") was reported by the chemistry module's user interface workstation (uiw) while the discordant result was obtained.The system posted the 0 umol/l result to the uiw.The expected behavior of the system is to report "error".Siemens is further investigating this issue.Section(s) h6 and h10 were updated to reflect the additional information.

• Brand Name: ATELLICA CH 930 MODULE
• Type of Device: ATELLICA CH 930 MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9281358
• MDR Text Key: 216660322
• Report Number: 2432235-2019-00387
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: 00630414002163
• Combination Product (y/n): N
• PMA/PMN Number: K151767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA CH 930 MODULE
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2432235-03/06/2020-006-C
• Patient Sequence Number: 1
• Patient Age: 57 YR