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 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ and na+ results were obtained from a non-vitros biorad level 1 quality control fluid processed using vitros k+ and na+ slides in combination with a vitros 5600 integrated system.The event was isolated to the calibration events performed on 29 and 30 august 2018 using the same calibrator kit lot 0277.The calibrations were suboptimal when compared to the typical calibration responses and parameters.The most likely cause of the suboptimal calibrations was user error.The customer suspected the calibrator fluids in use were not properly reconstituted due to user error, although this could not be definitively confirmed.Acceptable vitros na+ and k+ performance was observed after a recalibration event was performed using properly handled calibrator fluids.

Event Description

The customer obtained higher than expected vitros k+ and na+ results from a non-vitros biorad level 1 quality control fluid processed using vitros k+ and na+ slides in combination with a vitros 5600 integrated system.Biorad level 1, lot 47960 na+ results of 143.0, 142.7, and 158.1 mmol/l vs.The expected result of 115.0 mmol/l.Biorad level 1, lot 47960 k+ result of 3.70 mmol/l vs.The expected result of 2.50 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 unexpected vitros na+ and k+ results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.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: 7909689
• MDR Text Key: 124704781
• Report Number: 1319808-2018-00025
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 1662659
• Device Lot Number: 0277
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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