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

Model Number ATELLICA CH 930 MODULE

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics, inc.Has confirmed that the atellica ch 930 module may report incorrect serum indices for hemolysis (h) and lipemia (l) when using the un_c test as a donor method, and the hemolysis icterus lipemia (hil) function is enabled.Due to bubbles in the reaction cuvette, there is a potential for falsely depressed 'h' results (e.G.H index of 3 or higher, reported as less than or equal to 1 ) at a rate of 0.3-1% and falsely elevated 'l' results (e.G.L index of 0 reported as more than or equal to 1) at a rate of 2.9%.In all cases of falsely depressed h, l is elevated more than or equal to1.For samples not using un_c as the donor method the indices are not impacted.An urgent medical device correction (umdc) asi19-02.A.Us was sent to us customers and an urgent field safety notice (ufsn) asi19-02.A.Ous was sent to ous customers in july 2019.The umdc and ufsn advise customers who have multiple atellica ch 930 analyzers to generate un_c results on a different analyzer than the hil tests.For customers who have only one atellica ch 930 analyzer when un_c is part of the test order and alt and ast are not, hil tests should be ordered separately, or alternatively hil ordering can be turned off.

Event Description

One discordant, falsely elevated lipemia (l) index was obtained on a single patient sample when using atellica ch 930 module.When looking at the sample it did not appear that it was lipemic.Customer reported that they noticed that this has happened several times before as well, but only provided the results of one sample.The initial index was flagged incorrectly and was reported to the physician(s).The repeat index from another atellica ch 930 analyzer (serial number (b)(4)) was correct and reported to the physician(s).

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2019-00269 on 8-aug-2019.Additional information (23-sep-2019): siemens headquarters support center (hsc) performed additional investigation to determine if the elevated lipemia value was related to escalation review council (erc) 20190510-is-sys-2481-cm which is also related to field action asi 19-02.Hsc found that lipemia was not run with the un_c method, and therefore not related to fa asi 19-02.The analyzer takes absorbance measurements on the cuvette at 2 different wavelengths for each interferent and then converts these measurements into index values.The index values provide a semiquantitative representation of the level of hemolysis (h), icterus (i), and lipemia (l) in the sample.The lipemia (l) technique is calibrated to intralipid, not triglyceride.The l index corresponds to turbidity, not triglyceride content of an individual specimen.This would explain such a discrepancy between sample appearance, and the value generated for the lipemia measurement.As stated inside atellica operator guide: "the calculation tab of the h (hemolysis), i (icterus), and l (lipemia) test definitions in ch test definition enables laboratories to customize each index level at laboratory-defined absorbance values.Seven index levels (0-6) are available for customization.Laboratories can modify the upper limit of each interval, except for index level 6.The system automatically adjusts the lower limit of the next index level to ensure the intervals are continuous.Laboratories cannot decrease the value of the limit for index level 0 below the minimum value for the interferent, but they can increase the value.In addition, laboratories cannot increase the value of the upper limit of index level 5 beyond the maximum value for the interferent, but they can decrease the value." hsc recommends adjusting these limits to suit customer expectation.This event does not represent a non-conformance, but rather lipemia results did not meet the expectation of the customer.The instrument is performing within specification.No further evaluation of the device is required.Section h10 is 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: 8875509
• MDR Text Key: 218991772
• Report Number: 2432235-2019-00269
• 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
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2432235-08/06/2019-002-C
• Patient Sequence Number: 1