MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The issue happens regardless of the position of the tube on the rack and occurs intermittently with some labels or a series of labels.The issue has been happening intermittently after the installation of a new software version in (b)(6) 2020 and not all samples are showing the problem.The manual barcode reader reads the sample ids correctly.Siemens is investigating the issue.
Event or Problem Description
The customer reported that an extra character is occasionally added to the end of the patient sample ids when the sample barcode is read by the autosampler barcode reader on the customer's advia 2120i hematology system with dual aspirate autosampler.The extra character added is random and can change for the same sample id across multiple aspirations.There are no reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2020-00387 on 18-sep-2020.Corrected data (14-oct-2020): the date of event in section b4 has been changed to 16-jan-2020.The date received by manufacturer in g3 has been changed to 22-apr-2020.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2020-00387 on 18-sep-2020.Siemens filed the first supplemental mdr 2432235-2020-00387_s1 on 16-oct-2020.Additional information (19-nov-2020): the advia 2120/2120i software can handle up to fourteen characters on the barcode.The advia 2120/2120i software can read barcode encoded selectivity based on special characters encoded into the first position of the sample id (sid) barcode.For example, a (-) sign encoded in the first position of the barcode means to run a complete blood count (cbc) and an (=) sign means to run a cbc/reticulocyte test.In versions of software prior to 6.10 and 6.11 the system would automatically detect barcode selectivity and run the corresponding test encoded.In software versions 6.10/6.11, a feature was introduced where the barcode selectivity can be disabled by the operator.Once disabled it is expected that the software will not determine selectivity from the barcode.An issue with the software has been discovered where the barcode is misinterpreted when barcode encoding is disabled.This causes the first encoded character to be removed and the remaining 13 digits to be shifted to the left, and a random character/digit is added to the 14th position.The customer is operational with a manual workaround of collecting all the results via the export file and removing the last digit of the sid barcode.The cause of the event is a software error.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2020-00387 on 18-sep-2020.Siemens filed the first supplemental mdr 2432235-2020-00387_s1 on 16-oct-2020.Siemens filed the second supplemental mdr 2432235-2020-00387_s2 on 24-nov-2020.Additional information (25-feb-2021): an urgent medical device correction (umdc) hsw21-01.A.Us ("potential sample identification (sid) mismatch with 14-character barcodes") was sent to us customers and an urgent field safety notice (ufsn) hsw21-01.A.Ous ("potential sample identification (sid) mismatch with 14-character barcodes") was sent to outside the us (ous) customers in march 2021.The umdc and ufsn explain that advia 2120/2120i hematology system software versions 6.10 and 6.11 may misread patient sample 14-character sample identification (sid) barcodes which contain a non-alphanumeric character.The correction only applies to advia 2120/2120i hematology systems running software version 6.10 or 6.11 and customers that have disabled the barcode encode selectivity feature.Siemens recommends that customers using 14-character barcodes ensure that the barcode encoding selectivity feature is enabled.To date, there are no allegations of injury due to this behavior.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 10557073
• Report Number: 2432235-2020-00387
• Device Sequence Number: 3145639
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 11/19/2020; 02/25/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/16/2020; 11/25/2020; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-03/10/2021-001-C
• Patient Sequence Number: 1