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 06/04/2019

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

Two discordant, falsely elevated lipemia (l) index were obtained on atellica ch 930 module.The initial indices were flagged incorrectly and were not reported to the physician(s).The repeat index for (b)(6) using another atellica ch 930 module (serial number (b)(4)) was correct and reported to the physician(s).The other sample id was referenced by the customer with elevated l results.A repeat result was not provided by the customer for the additional sample id.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lipemia result.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00268 on 14-aug-2019.Additional information (16-aug-2019): sections b5 and b6 were updated to correct the information provided in the initial mdr.Mdr 2432235-2019-00291-s1 was filed for the same event.

Event Description

The repeat index was provided for sid (b)(6) and was considered correct.The repeat index was reported to the physician(s).

• 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: 8893811
• MDR Text Key: 196269394
• Report Number: 2432235-2019-00268
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2432235-08/06/2019-002-C
• Patient Sequence Number: 1