MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Device Problem Low Test Results (2458)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

The customer noted that the pct assay (configured two months before the notified event) reports zero (0) decimal places, instead of 2 decimal places.The distributor found that for the sample id reported by the customer the result was communicated by the third party instrument (alinity) as 0.87, truncated at zero decimal places by dms, communicated to third party upper middleware as 0 and finally reported to lis as <0.02.The distributor is still evaluating other potential impacted results/patients.The customer stated that some patients may have missed the antibiotic's treatment due to low pct results, considering that their normal range for pct is <0.5.The customer did not report any impact on patients health of any of the involved patients.

Manufacturer Narrative

The distributor confirmed that dms (automation's software module that manages the communication between lis/upper middleware and third party instruments) behaved as expected based on the set configuration (zero decimal places for pct assay).By design, inpeco automation system allows the users to configure many options (including number of decimal digits) and functionality for the management of results in accordance to their needs.The configuration of the software parameters is done by service personnel once the devices are already on the field.The configured rules are defined according to the specific instructions provided by the laboratory director/professionals who is responsible for the correctness of the configurations from a clinical point of view.The issue has been solved by the distributor fse that changed the configuration of decimal places from zero to two for pct assay.

• Brand Name: ACCELERATOR A3600
• 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: 15925867
• MDR Text Key: 307997875
• Report Number: 3010825766-2022-00008
• Device Sequence Number: 1
• Product Code: CEM
• 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
• Report Date: 12/06/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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