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

Catalog Number 6802584

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros creatinine (crea) results were obtained from different samples from a single patient using vitros chemistry products crea slides lot 1525-3492-0523 on a vitros 5600 integrated system.The results were higher than expected when compared to non-vitros results (beckam coulter method) obtained at a reference laboratory.The likely assignable cause of the higher than expected vitros crea patient sample results is an interferent in the samples from the patient that affects the vitros crea assay.One potential interferent is creatine as the vitros crea ifu lists creatine as an interferent that will cause a dp flag for the vitros crea assay.According to the vitros crea instructions for use (ifu), a dp code indicates high background density, usually due to an elevated creatine concentration.The customer stated that the physician who questioned the crea results indicated that based on the patient medical history the patient was likely taking creatine.The vitros analyzer posted dp codes while testing the patient samples neat and subsequently performed several dilutions per the ifu before they obtained crea results within the assay measuring range.In addition, the patient was taking multiple medications at the time of the event and interference with those medications could not be ruled out as potential contributors to the event.Based on historical quality control results, a vitros crea lot 1525-3492-0523 performance issue is not a likely contributor to the event.Furthermore, 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 1525-3492-0523.Within run precision testing was not performed on the vitros 5600 integrated system.However, there was no evidence indicating that the vitros 5600 integrated system was a contributor to the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not 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 samples, although this could not be confirmed.

Event Description

A customer obtained higher than expected vitros creatinine (crea) results from different samples from a single patient using vitros chemistry products crea slides lot 1525-3492-0523 on a vitros 5600 integrated system.The results were higher than expected when compared to non-vitros results (beckam coulter method) obtained at a reference laboratory.Patient sample 1 vitros crea result of 2.24 mg/dl versus an expected result of 1.14 mg/dl.Patient sample 2 vitros crea result of 1.53 mg/dl versus an expected result of 1.13 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros crea results were reported from the laboratory.However, a physician questioned the results and no treatment was initiated, altered or stopped based on the higher than expected results.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9467129
• MDR Text Key: 214628974
• Report Number: 1319809-2019-00122
• Device Sequence Number: 1
• Product Code: JFY
• 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
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 6802584
• Device Lot Number: 1525-3492-0523
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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