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

Catalog Number 6802584

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros crea results were obtained from a non-vitros biorad quality control fluid when tested on a vitros 350 chemistry system.A definitive assignable cause could not be determined at this time.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 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.A software related issue cannot be ruled out as a possible contributor as the same issue occurred with another assay processed around the same time.The tsc will continue to work with the customer to investigate and resolve.Email address for contact office above is (b)(4).

Event Description

The investigation determined that higher than expected vitros crea results were obtained from a non-vitros biorad quality control fluid processed using vitros crea slides when tested on a vitros 350 chemistry system.Biorad lot 56630 level 1 results of 367, 362, 359, 364, 349 and 361 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 patient samples were affected.The higher than expected vitros crea results were obtained from non-patient quality control fluids and patient samples were not affected.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There have been no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics complaint number (b)(4).This report is number one of six 3500a forms filed for this event, as six devices were affected.

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11543930
• MDR Text Key: 247282865
• Report Number: 1319809-2021-00021
• 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: 03/22/2021

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: 03/01/2021
• Initial Date FDA Received: 03/22/2021
• 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