MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802445
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ammonia (amon) results were obtained from a non-vitros biorad quality control fluid processed using vitros chemistry products amon slides lot 1019-0264-4175 on a vitros 4600 chemistry system.The assignable cause of the lower than expected vitros amon results is an instrument issue related to microslide incubator contamination.Historical quality control results were imprecise.The cause of the microslide incubator contamination is unknown, however, a possible contributor is user error which included using ethanol to clean the vitros 4600 system.An ortho field engineer performed maintenance actions on the vitros 4600 system which included decontamination cleaning of the microslide incubator, replacing the cm/rt evaporation caps, replacing the reflectometer lamp and lens and performing correction factors.Following maintenance actions and a recalibration event, quality control results returned to expectations.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ammonia (amon) results were obtained from a non-vitros biorad quality control fluid processed using vitros chemistry products amon slides lot 1019-0264-4175 on a vitros 4600 chemistry system.Biorad lot 54410 level 2 results of 73.1 and 42.9 umol/l vs an expected result of 91.6 umol/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 amon results were obtained when processing a control fluid.No results were reported out of the laboratory.The customer stated that no patient results had been affected or questioned.There has been no reported 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).

• Brand Name: VITROS 4600 CHEMISTRY SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20771953
• Report Number: 1319681-2024-00063
• Device Sequence Number: 4388460
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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 Catalogue Number: 6802445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown