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 Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros creatinine (crea) results were obtained from two different samples from a single patient processed using vitros chemistry products crea slides lot 1531-3499-6999 on a vitros 4600 chemistry system.The likely cause of the event was an issue related to the vitros crea slide cartridge that the samples were processed on.The issue with the cartridge is unknown.The higher than expected patient sample results were all processed from the same vitros crea reagent cartridge.In addition to the higher than expected patient sample results, higher than expected vitros crea quality control results were also obtained from the same reagent cartridge.Following a switch to a new vitros crea slide cartridge, repeat results of the quality control fluids as well as the initial patient sample were as expected.The vitros crea slide cartridge which produced the higher than expected results is no longer available for further investigation.It was confirmed that the customer was following correct sample handling protocol per the sample tube manufacturer indicating that a sample related issue is not a likely contributor to the event.Historical quality control results were acceptable as well as the results of a vitros crea within run precision test indicating that the vitros crea slides did not likely contribute to the event.A vitros alkp precision test yielded acceptable results indicating that the vitros 4600 chemistry system was not a likely contributor to the event.

Event Description

A customer reported higher than expected vitros creatinine (crea) results obtained from two different samples from a single patient processed using vitros chemistry products crea slides in combination with a vitros 4600 chemistry system.Patient 1 sample 1 vitros crea results of 11.3 and 10.0 mg/dl vs.The expected result of 1.0 mg/dl.Patient 1 sample 2 vitros crea result of 11.3 mg/dl vs.The expected result of 1.0 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 11.3 mg/dl was reported outside of the laboratory, however, the result was questioned by the physician and no treatment was administered.A corrected report was issued and there was no allegation of patient harm as a result of this event.This report is number 3 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.This report corresponds to ortho clinical diagnostics inc.(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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10049925
• MDR Text Key: 225928984
• Report Number: 1319809-2020-00062
• 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: 05/12/2020

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: 07/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1531-3499-6999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/19/2020
• Initial Date FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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