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

Model Number AP2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

The customer is using codabar barcode symbology without check digit and the range is configured from 2 digits to 23 digits.Based on the provided information the sid misreads occur only on uncapped sample tubes received from a specific blood collection center.The event is currently under investigation to determine if the quality of the label is compatible with the minimum print quality requirements.

Event Description

The customer reported several cases of misread sample tube ids (sids) on the tube identification modules at the input modules.In case the misread sid belongs to a sample tube (tube b) which is expected to be loaded on the automation system and has pending test orders, the wrongly identified sample tube (tube a) is tested according to the orders received for tube b.If the sample tubes is sent to a module or to a third party analyzer which checks the sample id the sample tube is flagged with sample id mismatch error and it is sent to the input/output module.Otherwise, if the tests are executed by an analyzer which do not read the sid, the mismatch error is not detected and the test results are associated to the wrong patient.When the sample tube b is actually loaded on the automation system it is flagged with error sc00e "duplicate sample id" and unloaded into the priority output rack of the input output module to be manually handled by the operators.No cases of actual erroneous results nor impacts on patient care have been reported from the field.

Manufacturer Narrative

The initial report (mdr 3010825766-2022-00002 ) was submitted on may 13th, 2022.Referring to the supplemental report (mdr 3010825766-2022-00002 s1) submitted on aug.4th, 2022, the actual percentage of label not compatible with the minimum print quality requirements is 7.5% instead of 12.5% previously communicated.

Manufacturer Narrative

Initial report (mdr 3010825766-2022-00002) was submitted on may 13th, 2022.Additional information: the distributor sent to inpeco some examples of tube labels to assess the print quality.The analysis showed that some of the provided labels (12,5%) were not compatible with the minimum print quality requirements.The poor label quality may affect the sample id readings at the tube identification modules and it may lead to a sid misreading.With the provided data it has not been possible to identify other causes.Inpeco suggested the customer to upgrade the tube identification module firmware to the last version in which issues of sample id not read (not strictly related to the scenario reported from the field) were improved.Inpeco offered assistance to correctly calibrate the camera.

• Brand Name: APTIO AUTOMATION
• Type of Device: 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: 14394612
• MDR Text Key: 291615157
• Report Number: 3010825766-2022-00002
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)210610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP2
• Date Manufacturer Received: 08/23/2022
• 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
• Patient Sequence Number: 1