MAUDE Adverse Event Report: INPECO SA APTIO AUTOMATION; LABORATORY AUTOMATION SYSTEM

Model Number	AP2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the log files analysis provided by the product distributor, it was found that: sid (b)(6) arrived at the stago sta-r analyzer first, followed by sid (b)(6).After the processing at the analyzer, the sid (b)(6) was released but it was returned with the sid of the following sample tube.Then, the sid (b)(6) was processed by the analyzer.The sid was correctly read at the barcode reader at the exit of the module, but it was released with the error sc00e "duplicate sample id".The real sid (b)(6) followed the path for sid (b)(6): in this case, it was sent to sorting rack of iom since it did not have any pending test order to be performed.The real sid (b)(6) was sent to priority output rack of the iom since it was flagged with the error sc00e.In both cases, since the sample tubes were sent to specific racks, they shall be manually managed by the laboratory operator, who became aware of the event.No impact on patient care was reported, and no incorrect results were generated.The investigation is still ongoing to identify the root cause.
Event or Problem Description
The customer reported that a tube with sample identification number (sid) (b)(6) was released by the stago sta-r analyzer interface module with the error sc00e "duplicate sample id".According to the graphical user interface, that sid was located in a sorting rack of the input output module (iom), but when the operator took the sample tube from the sorting rack, he saw that the sid was not (b)(6).The real sid (b)(6) was in another rack of the iom named (b)(6).The stago sta-r analyzer is not under inpeco responsibility and it is connected to the inpeco aptio automation system through an interface module, composed by a "pick and place" robotic sample moving device designed to transfer the sample tubes to and from the analyzer.The interface module has a barcode reader at the exit of the module, which reads the sid on the label of the sample tube.
Additional Manufacturer Narrative
The initial report (3010825766-2021-00007) has been submitted on (b)(6) 2021.Additional information: according to the investigation, the root cause of the event is a firmware bug which might lead to the release of a sample tube with the wrong id from the stago star interface module.Inpeco has released a new firmware version.The upgrade to this version has not been evaluated mandatory in terms of recall.The probability of occurrence of the issue has been evaluated already improbable since no other cases have been reported from the field and it has not been possible to reproduce the event in house.Moreover, the operators have the possibility to become aware of the issue thanks to the error sc00e "duplicate sample id" associated to the sample tube wrongly identified as duplicate.

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 11642219
• Report Number: 3010825766-2021-00007
• Device Sequence Number: 3050000
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)190128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: AP2
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown