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

Catalog Number 6802584

Device Problem High Test Results (2457)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected creatinine results were obtained from two different samples from a single patient and a non-vitros biorad quality control fluid processed using vitros chemistry products crea slides lot 1523-3498-5583 on a vitros 350 chemistry system.A definitive assignable cause could not be determined.Based on historical quality control (qc) results, a vitros crea reagent lot 1523-3498-5583 performance issue is not a likely contributor of the event.However, the higher than expected patient sample results and qc results were obtained using this reagent lot while acceptable results were obtained from the same samples using an alternate vitros crea reagent lot.Therefore, an issue related to slide cartridge handling and storage of the affected vitros crea cartridges cannot be ruled out as a potential contributor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1523-3498-5583.Although precision testing was not performed on the vitros 350 chemistry system, an instrument related issue was not likely a contributor to the event as historical qc results were precise and acceptable results were obtained using an alternate lot of vitros crea reagent without any service actions being performed on the vitros 350 system.Email address for contact office in manufacturer field is (b)(4).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected creatinine results obtained from quality control (qc) fluids and two different samples from a single patient processed using vitros chemistry products crea slides on a vitros 350 chemistry system.Patient (b)(6) sample (b)(6) crea results of 264 and 270 umol/l vs.The expected result of 66 umol/l.Patient (b)(6) sample (b)(6) crea results of 278 and 270 umol/l vs.The expected result of 62 umol/l.Biorad lot 56630 level 1 crea results of 362, 361, 368, 356 and 359 umol/l vs.The expected result of 66 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros crea patient sample results of 264 umol/l and 278 umol/l were reported from the laboratory.However, a physician questioned the results and corrected reports were later issued.No treatment was initiated, altered or stopped based on the higher than expected results and there have been no allegations of patient harm as a result of this event.This report is number 6 of 9 mdr¿s for this event.Nine (9) 3500a forms are being submitted for this event as 9 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4) / ivd (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11339955
• MDR Text Key: 276245543
• Report Number: 1319809-2021-00008
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

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: 06/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3498-5583
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1