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

Catalog Number 1707801

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros glucose (glu) results were obtained from multiple patient samples when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros glu reagent lot 0049-0967-1567 performance issue is not a likely contributor of the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0049-0967-1567.A review of e-connectivity data from the vitros 5600 integrated system determined that over the timeframe of the event, there were separate groupings of patient sample results of <20 mg/dl from two different reagent slots in the vitros 5600 integrated system.In addition, between the groupings of the lower than expected results there were other patient sample results that were within expectations.This indicates that a non-reactive vitros glu slide cartridge is not a likely cause of the event.It is possible an issue with the affected slides contributed to the event, but this cannot be confirmed.An ortho field engineer (fe) performed adjustments to the microslide metering assembly of the vitros 5600 integrated system.Post service marker precision testing on the vitros 5600 integrated system yielded results that were within acceptable guidelines indicating that the instrument had been returned to expected operation.However, because precision testing was not conducted prior to service actions an issue with the vitros 5600 integrated system cannot be concluded nor ruled out as a contributor to the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer obtained lower than expected vitros glucose (glu) results from multiple patient samples when tested on a vitros 5600 integrated system.Patient 1 sample result of <20 mg/dl vs the expected result of 120 mg/dl.Patient 2 sample result of <20 mg/dl vs the expected result of 201 mg/dl.Patient 3 sample result of <20 mg/dl vs the expected result of 122 mg/dl.Patient 4 sample result of <20 mg/dl vs the expected result of 144 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if the issue were to occur undetected on patient samples.The lower than expected vitros glu results were not reported outside the laboratory.There was no allegation of actual patient harm as a result of this event.This report is number one of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 9197695
• MDR Text Key: 214617090
• Report Number: 1319809-2019-00104
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 1707801
• Device Lot Number: 0049-0967-1567
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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