MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number 1882208

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected creatinine result was obtained from a vitros performance verifier quality control fluid using vitros chemistry products crea slides lot 1537-3513-1390 on a vitros 5600 integrated system.The assignable cause of the higher than expected vitros crea quality control results is a suboptimal calibration.The cause of the suboptimal calibration is likely due to an issue related to the preparation of vitros cal kit 1 lot 0121.A finn pipette was used to initially reconstitute the vials of vitros cal kit 1.The instructions for use (ifu) for vitros cal kit 1 recommends using either a class a volumetric pipette or an automated pipette due to the sensitivity of the reconstitution process in maintaining the accuracy of the products.Recalibration with freshly prepped calibrator fluids using volumetric pipettes resolved the issue.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 vitros crea reagent lot 1537-3513-1390 yielded acceptable qc results in combination with the vitros 5600 integrated system after a recalibration event without any troubleshooting actions being performed on the instrument.Email address for contact office is (b)(4).

Event Description

The investigation has determined that a higher than expected creatinine (crea) result was obtained from a vitros performance verifier (pv) quality control fluid using vitros chemistry products crea slides lot 1537-3513-1390 on a vitros 5600 integrated system.Vitros pv i u8105 result of 1.60 mg/dl vs.The expected result of 0.96 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros crea result was obtained from a quality control fluid 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 number (b)(4).

• 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 Key: 12478174
• MDR Text Key: 272901189
• Report Number: 3007111389-2021-00126
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Catalogue Number: 1882208
• Device Lot Number: 0121
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1