MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS GLU SLIDES; IN VITRO DIAGNOSTICS

Catalog Number 1707801

Device Problem Low Test Results (2458)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros glucose (glu) result was obtained from a linearity fluid sample processed using vitros chemistry products glu slides on a vitros 5600 integrated system.An assignable cause of this event could not be determined.Historical quality control results indicated that the vitros glu reagent was not meeting expectations for day to day precision performance and therefore, a reagent related issue could have contributed to the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros glu reagent lot 0041-0944-5838.There was no indication of a systemic issue with the vitros 5600 integrated system.However, because precision testing was not completed, an instrument related issue cannot be completely ruled out as a contributing factor.Additionally, a calibration issue was ruled out as a contributing factor to the event as the retest of the sample was performed using the same calibration.Furthermore, an issue related to the linearity fluid sample was ruled out as a contributing factor.

Event Description

A customer reported a lower than expected vitros glucose (glu) result from a fluid sample of a linearity verification study processed using vitros chemistry products glu slides in combination with a vitros 5600 integrated system.Linearity fluid (ln2) vitros glu result of 1.29 mmol/l versus an expected result of 7.64 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 lower than expected vitros glu result was reported to the (b)(6) proficiency supplier.However, the result was attained from a linearity sample fluid which was later re-tested and expected results were reported out.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected or would not be affected if the event were to recur undetected.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 GLU SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8284948
• MDR Text Key: 136852517
• Report Number: 1319809-2019-00003
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: KU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1707801
• Device Lot Number: 0041-0944-5838
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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