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

Model Number ATELLICA CH 930 ANALYZER

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and the upper value of the measuring interval was modified back to 1,000 u/l.Siemens healthcare diagnostics investigated this issue regarding the atellica ch 930 analyzers.Siemens determined that if an operator edits test definition (tdef) parameters for an assay without "saving" the changes using the steps documented in the online help, and the operator abruptly selects another assay to edit, there is a potential for some of the edited parameters of the original assay to be overwritten by settings of the newly selected assay.This occurs if the "save" button on the dialog box is displayed after the selection of the new assay.If an overwrite of settings occurs, it can impact some or all of the tdef parameters on the display and potentially affect results for the affected assay.The probability of this issue occurring is extremely low and requires a specific timing window.Starting 27-feb-2020, 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 and request for customers to follow the instructions outlined in the "editing assay identification parameters in ch test definition" section of the atellica solution online help 1.20.The umdc and ufsn indicate that each tdef must be saved using the "save" button on the ch test definition screen before modifications on another assay's tdef are initiated and advise customers to verify that quality control results are not affected and that results, units, and flags are correctly reported for any tdef that has been updated before running patient samples.Additionally, the umdc and ufsn recommend that customer ensure all reagent packs have valid calibrations before running patient samples.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.Mdr 2432235-2020-00217 was filed for the same software behavior.

Event Description

The customer reported that the upper value of the measuring interval for the concentrated alkaline phosphatase (alp_2c) assay changed from 1,000 u/l to 60 u/l for serum and plasma sample types on an atellica ch 930 analyzer, without user intervention.This was apparent to the customer because high level quality control (qc) results were flagged with "e521: above assay range" even though the qc results recovered less than 1,000 u/l.There were no reports of discordant results or delay to patient testing.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA CH 930 ANALYZER
• Type of Device: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders, nj
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, ny ; 5243504
• MDR Report Key: 9802753
• MDR Text Key: 220254567
• Report Number: 2432235-2020-00216
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: 00630414002163
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-03/06/2020-006-C
• Patient Sequence Number: 1