MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5; IN VITRO DIAGNOSTICS

Catalog Number 1149764

Device Problem Low Test Results (2458)

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

Event Date 11/24/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected results were obtained from both a vitros quality control (qc) fluid and a non-vitros qc fluid using vitros chemistry products amon slides on a vitros 5600 integrated system.The investigation concluded that the most likely assignable cause was a calibration issue.The original calibration parameters were reviewed and deemed to be atypical.The calibrator values all appeared similar to each other, but were very high compared to average.After a new calibration event was executed using a fresh set of calibrators and a fresh vitros amon slide cartridge, both from the same lot, results were attained that were within expectations.The reagent performance after the new calibration was comparable to expectations.Therefore, the reagent can be ruled out as a contributing factor to the event.Furthermore, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros amon reagent lot 1018-0250-2979.Performance testing to verify the instrument was not completed.Although the instrument was not verified, there is no indication that the instrument contributed to the event.

Event Description

A customer reported lower than expected quality control (qc) results obtained from both vitros liquid performance verifier (pv) fluids and non-vitros quality control fluids using vitros chemistry products amon slides in combination with a vitros 5600 integrated system.Vitros liquid performance verifier ii lot g6496 result of <9 umol/l vs the expected result of 197.2 umol/l non-vitros mas quality control fluid result of <9 umol/l vs the expected result of 148 umol/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 results were attained from qc fluids.There were no reports of affected patient results and there were no allegations of patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5
• 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: 8178630
• MDR Text Key: 131920479
• Report Number: 1319808-2018-00048
• Device Sequence Number: 1
• Product Code: CIX
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: 1149764
• Device Lot Number: 0528
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2018
• 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