MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. CREATININE/IDMS STD/5PK/300SLD; IN VITRO DIAGNOSTICS

Model Number 6802584

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

A customer reported that higher than expected results were obtained from a single patient sample using vitros chemistry products creatinine (crea) slides lot 1542-3524-0157 processed on a vitros 5600 integrated system.Patient sample vitros crea results of 1.77 and 1.66 mg/dl vs the expected result of 1.1 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros crea result of 1.77 mg/dl initially obtained from the sample was reported outside of the laboratory.However, a corrected report was issued and no treatment was initiated, stopped or altered based on reported result.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected results were obtained from a single patient sample processed using vitros chemistry products creatinine slides lot 1542-3524-0157 on a vitros 5600 integrated system.The assignable cause of the event is creatine interference in the sample.The patient was taking creatine supplements.The concentration of creatine in the supplements was not provided.Per the vitros crea instructions for use (ifu), limitations of the procedure, known interferences: creatine: at a creatinine concentration of 1.5 mg/dl (133 ¿mol/l), creatine greater than 8 mg/dl (707 ¿mol/l) will be flagged with a dp code (because highly elevated creatine concentrations may cause excessive background density).At a creatinine concentration of 14 mg/dl (1237 ¿mol/l), creatine greater than 1 mg/dl (88 ¿mol/l) will be flagged with a dp code.Refer to ¿sample dilution¿ for dilution instructions.The vitros 5600 integrated system did not generate a vitros crea result when the patient sample was tested undiluted due to the occurrence of a ¿dp¿ sample code, which indicates substrate depletion.The most likely cause of the dp sample code is an interferent in the sample, such a creatine, which would be diluted out with the sample dilution prior to repeat testing.Per the vitros flags and codes on reports, the description for a dp sample code is substrate depletion and the suggested action is to dilute the sample and repeat the test.The higher than expected vitros crea results were obtained from 2x dilutions of the sample.The historical quality control data reviewed indicates the vitros crea slides and the vitros 5600 system did not likely contribute to the event as the quality control results were acceptable during the timeframe of the event.In addition, continual tracking and trending did not indicate a performance issue with vitros crea slide lot 1542-3524-0157.

• Brand Name: CREATININE/IDMS STD/5PK/300SLD
• Type of Device: 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15905679
• MDR Text Key: 308150014
• Report Number: 0001319809-2022-00600
• 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: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 6802584
• Device Catalogue Number: 6802584
• Device Lot Number: 1542-3524-0157
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1