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

Catalog Number 1707801

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

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

Event Date 08/21/2023

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 0023-3233-9322 on a vitros 5,1 chemistry system.Patient sample result of 35.2 mg/dl vs the expected result of 160.37 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.It is unknown if the lower than expected vitros glu results were reported from the laboratory, however it was confirmed that no treatment was administered based on any lower than expected results obtained.There was no 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 0023-3233-9322 on a vitros 5,1 chemistry system.The assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0023-3233-9322 performance issue cannot be fully ruled out as a potential contributor to the event.However, 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 0023-3233-9322.Although within-run vitros alkp precision testing was not performed to verify the vitros 5,1 system, an issue with the vitros 5,1 chemistry system is not a likely contributor to the event as acceptable vitros glu qc results were obtained between the times the lower than expected patient results were obtained with no service actions performed on the analyzer.It is unknown if the customer is following the collection device manufacturers recommended protocol, therefore it is possible that improper pre-analytical sample processing 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.An ortho service engineer reviewed the patient sample runs in e-connectivity and determined that there was no evidence of system failure or metering issues.The pressure profiles for both aspirate and dispense on the slide were not able to be retrieved, therefore a sample mix-up cannot be fully ruled out as a potential contributor to the event.

• 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: 17848036
• MDR Text Key: 324771471
• Report Number: 0001319809-2023-00123
• 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: 09/29/2023

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 Catalogue Number: 1707801
• Device Lot Number: 0023-3233-9322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1