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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER; CALCLUATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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DATA INNOVATIONS LLC INSTRUMENT MANAGER; CALCLUATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Model Number 8.16.20
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2020
Event Type  malfunction  
Event Description
Provider reported that a beckman remisol instrument is receiving identical specimen id numbers, but the patients are different.The later patient would have no orders attached.Investigation showed that there was no malfunction of the instrument manager software.Further investigation showed and was confirmed by the provider that the vista lis was configured incorrectly.There was no report of patient harm for this instance, but data innovations did not receive any further information about potential patient impact from other orders/results which occurred since the vista lis was misconfigured.
 
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Brand Name
INSTRUMENT MANAGER
Type of Device
CALCLUATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Manufacturer (Section D)
DATA INNOVATIONS LLC
120 kimball ave
suite 100
south burlington, vt
Manufacturer Contact
david russo
120 kimball ave
suite 100
south burlington, vt 
6582850
MDR Report Key9771892
MDR Text Key199875705
Report Number1225673-2020-00001
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/28/2020
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 Number8.16.20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/05/2020
Initial Date FDA Received02/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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