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

Catalog Number 6802584

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros creatinine (crea) results were obtained using vitros crea slides in combination with a vitros 5600 integrated system.The customer considered the non-vitros (labtest) results to be the expected crea results.The assignable cause of the event was not determined.There were no details provided regarding the patient diagnosis, medication list, or other assay results.Other than the data provided by the ortho laboratory specialist, there has been no additional investigation of the samples, reagent or analyzer.Therefore, a vitros crea slide lot issue, an instrument issue or a sample related issue cannot be ruled out as potential contributors to this event.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea lot 1522-3589-7685.

Event Description

A customer obtained lower and higher than expected vitros creatinine (crea) results using vitros crea slides in combination with a vitros 5600 integrated system.The customer considered the non-vitros (labtest) results to be the expected crea results.Sample 1 = 0.15 versus expected 3.60 mg/dl.Sample 2 = 0.15 versus expected 1.65 mg.Dl.Sample 3 = 0.20 versus expected 2.13 mg/dl.Sample 4 = 0.29 versus expected 2.36 mg/dl.Sample 5 = 0.49 versus expected 2.13 mg/dl.Sample 6 = 0.56 versus expected 1.96 mg/dl.Sample 7 = 0.73 versus expected 1.62 mg/dl.Sample 8 = 0.84 versus expected 1.69 mg/dl.Sample 9 = 0.94 versus expected 1.53 mg/dl.Sample 10 = 1.15 versus expected 1.68 mg/dl.Sample 11 = 1.28 versus expected 1.86 mg/dl.Sample 12 = 1.29 versus expected 1.71 mg/dl.Sample 13 = 1.37 versus expected 2.04 mg/dl.Sample 14 = 1.43 versus expected 3.06 mg/dl.Sample 15 = 1.50 versus expected 3.72 mg/dl.Sample 16 = 1.54 versus expected 1.06 mg/dl.Sample 17 = 1.98 versus expected 1.39 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower and higher than expected vitros crea results were not reported from the laboratory.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report is number two of seventeen mdr¿s for this event.Seventeen 3500a forms are being submitted for this event as seventeen devices were involved.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: 9125369
• MDR Text Key: 214598001
• Report Number: 1319809-2019-00080
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 6802584
• Device Lot Number: 1522-3589-7685
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• 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