MAUDE Adverse Event Report: DATA INNOVATIONS LLC ACCESORY TO INSTRUMENT MANAGER - ABBOTT ALINITY CI-SERIES DRIVER (ABDICQII); CALCULATOR/DATA PROCESSING MODULE

Model Number ABDICQII V8.00.0001

Device Problem Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

Customer cannot receive quality control results for abbott diagnostics alinity ci-series (abdicqii) instrument.Drivers are an accessory component of the instrument manager system which enables communications with laboratory instruments.This incident has been evaluated to be a driver accessory malfunction.When the instrument transmits result from a quality control (qc) sample id ("q^control" in spm segment), and hold results until complete is enabled, the result does not parse to instrument manager.Communication trace shows the sample being transmitted, but no information is logged in the specimen event log (sel).There is a potential for harm if qc results are not processed, downstream auto-verification rules may misfire based on missing qc results leading to a delay in, or incorrect treatment.In addition, qc results will not be available for evaluation by the lab.The site that reported the issue does not have downstream autoverification rules, so no patients were impacted.

• Brand Name: ACCESORY TO INSTRUMENT MANAGER - ABBOTT ALINITY CI-SERIES DRIVER (ABDICQII)
• Type of Device: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball ave; suite 100; south burlington VT 05403
• Manufacturer (Section G): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• Manufacturer Contact: david russo ; 120 kimball ave; suite 100; south burlington, VT 05403 ; 8022643490
• MDR Report Key: 7823475
• MDR Text Key: 118548419
• Report Number: 1225673-2018-00007
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: BK120051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/28/2018

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
• Device Model Number: ABDICQII V8.00.0001
• Was Device Available for Evaluation?: No
• Device Age: 18 MO
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1