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

Catalog Number 6802584

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

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros creatinine (crea) result was obtained from a single patient sample processed using vitros chemistry products crea slides lot 1503-3534-0931 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined with the information provided.Based on historical quality control results a vitros crea lot 1503-3534-0931 related issue is not a likely contributing factor of the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1503-3534-0931.An ortho field engineer performed periodic maintenance on the vitros 5600 system and cleaned a dusty film from the microslide incubator.However, as no precision testing was performed on the vitros 5600 integrated system an instrument related issue could not be completely confirmed or ruled out as a contributor of the event.Historical qc results were precise, indicating that an instrument related issue was not a likely contributing factor of the event.Additionally, 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.In addition, as no information regarding whether the patient had been taking any medications or supplements around the time of the event was provided, a sample interferent cannot be ruled out as a possible contributor of the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected vitros creatinine (crea) result was obtained from a single patient sample processed using vitros chemistry products crea slides lot 1503-3534-0931 on a vitros 5600 integrated system.Vitros crea patient 1 sample result of 0.73 mg/dl versus the expected result of 1.70 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 crea result was not reported outside of the laboratory.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).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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: 17480606
• MDR Text Key: 320778388
• Report Number: 0001319809-2023-00069
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: 10758750002849
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6802584
• Device Lot Number: 1503-3534-0931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1