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 08/19/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros na+ results were obtained from a single non-vitros biorad l1 quality control fluid, lot 31820, using vitros na+ slides on a vitros 4600 chemistry system.The event was isolated to the calibration event performed on 19 august 2017.In addition to the vitros na+ assay, the vitros k+ and cl- assays were also affected.The calibrations were suboptimal when compared to the typical calibration responses and parameters.The most likely cause of the suboptimal 19 august calibrations was user error, where the reconstituted calibrators (calibrator kit 257) were stored for too long at room temperature prior to use.Acceptable vitros na+ performance was observed after a recalibration event was performed using properly handled calibrator fluids.The investigation found no indication the vitros 4600 chemistry system or vitros na+ slide lot contributed to the event.

Event Description

The investigation determined that higher than expected vitros na+ results were obtained from a single non-vitros biorad l1 quality control fluid, lot 31820, using vitros na+ slides on a vitros 4600 chemistry system.Biorad l1 na+ results of 138.9, and 142.7 mmol/l vs.The expected result of 126.0 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.A review of vitros na+ results during the timeframe of the event determined that two patient samples were affected and higher than expected results were reported outside of the laboratory.However, corrected reports were issued and there were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: 6870639
• MDR Text Key: 87469884
• Report Number: 1319808-2017-00015
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Catalogue Number: 1662659
• Device Lot Number: 257
• Other Device ID Number: 10758750009503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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