MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN VITRO DIAGNOSTICS

Catalog Number 1662659

Device Problem High Test Results (2457)

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

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros sodium (na+) result was attained from a (b)(6) proficiency fluid when processed using vitros chemistry products na+ slides on a vitros 5600 integrated system.The historical biorad quality control results indicate the vitros na+ quality control precision was acceptable when compared to the biorad peer performance.However, the vitros na+ quality control accuracy was higher than the peer means for both levels of control indicating a consistent bias high.A review of the calibration parameters in use during the time interval reviewed confirm that the three calibrations were suboptimal and most likely the cause of the higher vitros na+ results.The customer recalibrated using an alternate vitros calibrator kit 32 and vitros na+ accuracy returned to expected performance post recalibration.The cause of the suboptimal calibrations was not determined.There was no precision testing performed to confirm the performance of the vitros 5600 integrated system and therefore, an instrument issue cannot be completely ruled out as a contributor to the event.

Event Description

A customer obtained a higher than expected vitros sodium (na+) result from a (b)(6) proficiency fluid when processed using vitros chemistry products na+ slides on a vitros 5600 integrated system.(b)(6) sample result of 135 mmol/l versus the expected result of 129.6 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros na+ result was from a (b)(6) proficiency fluid.No erroneous vitros na+ patient sample results were obtained or reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8946825
• MDR Text Key: 219866286
• Report Number: 1319808-2019-00031
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: 1662659
• Device Lot Number: 0298
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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