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

Model Number 1707801

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0019-3227-0206 on a vitros 4600 chemistry system.Patient sample result of < 20 mg/dl vs an expected result of 193 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros glu result was not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4)and reportability assessment (b)(4).

Manufacturer Narrative

The investigation has determined that a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0019-3227-0206 on a vitros 4600 chemistry system.A definitive assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0019-3227-0206 performance issue cannot be ruled out as a contributor to the event.As no precision testing was performed on the vitros 4600 chemistry system, an instrument related issue cannot be entirely ruled out as a contributor of the event.However, there was no indication that the analyzer malfunctioned, and historical qc results were precise indicating that an issue related to the performance of the vitros 4600 system was not a likely contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was 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 sample, although this could not be confirmed.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 0019-3227-0206.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17230969
• MDR Text Key: 318142052
• Report Number: 0001319809-2023-00053
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: 10758750009572
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 1707801
• Device Catalogue Number: 1707801
• Device Lot Number: 0019-3227-0206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1