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

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros creatinine (crea) patient sample results were obtained on two crea slide lots when tested on a vitros 5600 integrated system.The results were discordant compared to crea results obtained from non-vitros (labtest and roche) methods.There are no details provided regarding the patient diagnosis, medication list, or other assay results.Other than the data provided by the ortho laboratory specialist (ls), there has been no additional investigation of the samples, reagent or analyzer.Therefore, a crea reagent issue, an instrument issue or a sample related issue cannot be ruled out as potential contributors to this event.The ortho ls is expected to go on site and further investigate.No conclusions can be made at this time.The crea results from the two non-vitros methods were comparable and considered the ¿expected¿ results.Therefore, the lower than expected vitros crea results will be conservatively reported.

Event Description

A customer obtained lower than expected vitros creatinine (crea) patient sample results on two crea slide lots when tested on a vitros 5600 integrated system.The results were discordant compared to crea results obtained from non-vitros (labtest and roche) methods.Vitros crea lot 1522-3589-7685 (units mg/dl) sample 1 = 0.61 versus expected 1.79.Sample 2 = 0.22 versus expected 2.82 / 2.26.Sample 4 = 0.85 versus expected 2.54 / 2.03.Sample 5 = 0.72 versus expected 2.11 / 1.65.Vitros crea lot 1523-3491-9931 (units mg/dl): sample 9 = 0.33 versus expected 2.26.Sample 11 = 1.43 versus expected 2.03.Sample 12 = 0.81 versus expected 1.65.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros crea results were reported from the laboratory.It is unknown if there was any allegation of actual patient harm as a result of this event.This report is number four of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven 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: 8960221
• MDR Text Key: 214591778
• Report Number: 1319809-2019-00069
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3491-9931
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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