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

Model Number	1707801
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that non-reproducible, lower than expected glucose (glu) results were obtained from a multiple patient samples processed using vitros chemistry products glu slides lot 0023-3233-9483 on a vitros 250 chemistry system.The assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0023-3233-9483 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 0023-3233-9483.Within-run vitros alkp precision testing was within ortho acceptable guidelines, verifying that the vitros 250 system was performing as expected and that an issue with the vitros 250 chemistry system is not a likely contributor to the event.Prior to the patient samples being run, the customer obtained acceptable quality control results from the same vitros glu reagent cartridge.This indicates that an issue with this particular vitros glu cartridge is not a likely contributor to the event, however it cannot be confirmed that the issue was not isolated to the slides in question.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.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report non-reproducible, lower than expected glucose (glu) results were obtained from a multiple patient samples processed using vitros chemistry products glu slides lot 0023-3233-9483 on a vitros 250 chemistry system.Patient 2 sample result of <10.0 mg/dl vs the expected result of 192.0 mg/dl patient 4 sample result of <10.0 mg/dl vs the expected result of 170.0 mg/dl patient 5 sample result of <10.0 mg/dl vs the expected result of 186.0 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 results were not reported from the laboratory.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 is number two of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18676127
• Report Number: 1319809-2024-00023
• Device Sequence Number: 17698020
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: 10758750009572
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: 1707801
• Device Catalogue Number: 1707801
• Device Lot Number: 0023-3233-9483
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown