MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE CALCULATOR / DATA PROCESSING MODUL; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number V8.12.01

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911)

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

Event Date 05/07/2019

Event Type  Injury  

Event Description

Data innovations, the mfr of instrument manager software, was notified on (b)(6) 2019 by roche diagnostics that christine holland, the lead medical technologist at st elizabeth hosp reported that the following scenario occurred at st.Elizabeth's hosp on (b)(6) 2019: a specimen for pt a was collected and labeled with the appropriate barcode.A specimen for pt b was collected and labeled appropriately with pt b's barcode.Later, in the lab, pt b's specimen was relabeled incorrectly with a reprinted pt a barcode label.A troponin test, a cardiac health marker, was performed on both specimens and the result of pt b was reported to pt a's chart.No results were reported for pt b.The lab noticed pt b's pending troponin test on their pending log and the specimen was recollected and run.Pt a was admitted to the hosp for further workup based on the incorrect results.Pt b was already in-house and had a history of elevated troponin.Barcodes are generated outside of instrument manager.This was user error in applying an incorrect barcode to a specimen.This is not a malfunction of instrument manager.Report is being submitted due to the pt being admitted to the hospital.Fda safety report id# (b)(4).

• Brand Name: INSTRUMENT MANAGER SOFTWARE CALCULATOR / DATA PROCESSING MODUL
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS LLC; south burlington VT 05403
• MDR Report Key: 8696502
• MDR Text Key: 148069184
• Report Number: MW5087331
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V8.12.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization