MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR / DATA PROCESSING MODUL

Model Number V8.14.00

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/05/2019

Event Type  No Answer Provided  

Event Description

Roche diagnostics (a distributor of data innovations' instrument manager software) reported an issue to data innovations (di) on behalf of (b)(6): they reported that a vancomycin test was to be run on line 1 and line 2 of roche cobas 8000 instruments.A roche cobas 8100 instrument tried to run on line 2, but test was marked out of service in data innovations instrument manager software.A different roche cobas 8100 tried to run on line 1 but line 1 was down for maintenance.The specimen sat in aob (add on buffer, a module of the roche 8100 instrument) for four hours then was sent to the p501 for archiving (archive message is sent to the 8100, then specimen is routed to storage).The sample was discovered many hours later by a medical technologist who realized the sample was pending, retrieved it and put on the line 1 and received result.Line 1 cobas 8000 resulted it with the correct result, however earlier in the day the physician went ahead and treated the pt with vancomycin, when the result indicated later that the pt did not need to be treated with vancomycin.This instance was caught as having no pt harm but (b)(4) has not indicated they investigated for add'l incorrect treatments since going live with roce cobas 8100.Pt was treated incorrectly when they did not need the treatment.Roche diagnostics has corrected this workflow issue and is treating this as an operator error as someone was not monitoring the aob.This was not a malfunction of instrument manager.Report is being submitted due to data innovations becoming aware of the incorrect treatment of the pt with unreported outcome.(b)(4).

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR / DATA PROCESSING MODUL
• Manufacturer (Section D): DATA INNOVATIONS LLC; south burlington VT 05403
• MDR Report Key: 8981718
• MDR Text Key: 158638428
• Report Number: MW5089658
• Device Sequence Number: 1
• Product Code: JQP
• 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: 09/06/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: V8.14.00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• 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): Other