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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS
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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1882208
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
The investigation has determined that lower than expected lactate (lac) results were obtained from a non-vitros biorad quality control fluid and a vitros performance verifier (pv) using vitros chemistry products lac slides lot 3532-0115-2784 on a vitros 5600 integrated system.Biorad lot 45890 l3 result of 3.71 mmol/l vs the expected result of 5.40 mmol/l.Vitros pv ii lot e8959 results of 2.37, 2.37 mmol/l vs the expected result of 3.74 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros lac results were obtained from quality control fluids and no results were reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).
 
Manufacturer Narrative
The investigation has determined that lower than expected lactate (lac) results were obtained from a non-vitros biorad quality control fluid and a vitros performance verifier using vitros chemistry products lac slides lot 3532-0115-2784 on a vitros 5600 integrated system.The assignable cause of the lower than expected vitros lac results was a suboptimal calibration.The parameters from the initial calibration of reagent lot 3532-0115-2784 used to obtain the lower than expected results were atypical compared to the database values.Following a recalibration event, vitros lac calibration parameters and quality control results returned to expectations.The cause of the suboptimal calibration was not determined.Freshly prepared vials of vitros calibrator kit 1 lot 0131 were used for the recalibration event.Calibrator fluid preparation of the initial vials was a possible contributor of the suboptimal calibration, however this could not be confirmed or ruled out.Although precision testing was not performed on the vitros 5600 integrated system, an instrument related issue is not a likely contributor of the event as quality control results were returned to expectations after a recalibration event without any known troubleshooting actions being performed on the instrument.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3532-0115-2784.(b)(4).
 
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Brand Name
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Type of Device
IN-VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
1000 lee road
rochester NY 14606
Manufacturer Contact
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key13830737
MDR Text Key297499288
Report Number3007111389-2022-00025
Device Sequence Number1
Product Code JIX
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 Other
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/20/2023
Device Catalogue Number1882208
Device Lot Number0131
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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