MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number APTIO AUTOMATION

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

Siemens healthcare investigated an internal complaint for the aptio automation storage and retrieval module (srm) that may lead to an incorrect association of test result(s) to a sample id and therefore to an incorrect patient result.The mis-association of test results, or a delay in testing, may occur when all the following conditions occur: the srm module is releasing a sample tube (tube a) just placed into the carrier, another sample tube (tube b) is erroneously not diverted into the srm module buffer, and number 1 and 2 occur within a very narrow timing window of each other.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

Siemens healthcare investigated an internal complaint for the aptio automation storage and retrieval module (srm) that may lead to an incorrect association of test result(s) to a sample id and therefore to an incorrect patient result.The mis-association of test results, or a delay in testing, may occur when all the following conditions occur: the srm module is releasing a sample tube (tube a) just placed into the carrier, another sample tube (tube b) is erroneously not diverted into the srm module buffer, and number 1 and 2 occur within a very narrow timing window of each other.An urgent medical device correction (umdc) lasw23-02.A.Us was sent to us customers and an urgent field safety notice (ufsn) lasw23-03.A.Ous was sent to outside the united states (ous) customers in may of 2023.The umdc and ufsn explain the behavior described above and requests customers to follow the instructions of the umdc/ufsn to ensure correct operation of the systems.The umdc and ufsn delineate that that a new version of firmware for the aptio automation storage and retrieval module (srm) will correct the issue.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; registration #: 3005509212; val della torre (torino), 10040 ; IT 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16945025
• MDR Text Key: 315908718
• Report Number: 2517506-2023-00156
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• 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: 2517506-05/17/2023-C
• Patient Sequence Number: 1