MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE

Model Number 10282969

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

The optional handheld barcode scanner used for the dca vantage analyzer allows scanning of operator id, patient id, sample demographics, and comments.Barcodes with a check-digit have an additional digit at the end of the unique alpha/numeric string, providing an extra functionality that should reduce the frequency of erroneous scans.The scanner is not confirming the integrity of read barcode data using the check-digit.As a result there are three issues identified with the reading of code 39 barcodes using handheld barcode scanner ds4308: the scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for sample id, patient id and comments because it matches an existing sample id, patient id or comments value.This can cause the results of a particular sample to be mis-identified and potentially assigned to a different patient.In order for this unlikely event to occur, incorrect decoding of the barcode by the scanner must occur, and the incorrect sample id, patient id and comments must match a different existing sample id, patient id or comments.The scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for sample id, patient id and comments that does not match any existing sample id, patient id or comments.This may lead to the sample being unmatched until the correct patient id is entered.The scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for operator id.If this occurs two effects are possible.It may prevent the user from being immediately authenticated.This issue can be mitigated by rescanning the barcode.If the incorrect operator id matches a different existing operator id with added permissions the operator could have access to additional dca functions.This issue was found internally.There are no reported customer complaints.

Event Description

Internal testing has determined that the dca vantage external barcode scanner model ds4308 does not operate as intended when using code 39 with check digit enabled barcodes.There is a remote possibility of incorrect identification of patient results by the medical device when using this barcode scanner to scan patient ids with the indicated symbology.There have been no reports of injury due to this defect from customers.

Manufacturer Narrative

Siemens reviewed the log file provided by the customer.The log file provided only contained testing data for the time period of may 13th to may 20th 2020.The false positive results provided in the printouts occurred over the time period of april 27th to april 30th 2020.The log file was reviewed for examination of instrument performance during the specific week in may.Aspiration profiles for all events were plotted and there were no anomalies noted.Ptest values for all aspiration profiles were in the normal range.Error types and error rates were reviewed with nothing atypical occurring.Analysis shows no evidence of the instrument working improperly.The cause of this event is unknown.

• Brand Name: DCA VANTAGE
• Type of Device: DCA VANTAGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10169455
• MDR Text Key: 197014306
• Report Number: 3002637618-2020-00027
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: 00630414551364
• Combination Product (y/n): N
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10282969
• Device Catalogue Number: 10282969
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1