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 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected creatinine (crea) result was obtained from a non-vitros (randox) quality control (qc) fluid when tested using vitros chemistry products crea slides lot 1519-3490-8161 on a vitros 5600 integrated system.The assignable cause is likely related to the single microslide, although the issue with the specific slide could not be determined.A review of e-connectivity was performed by an ortho second level engineer and it was determined that all of the other slides in the same cartridge resulted as expected, indicating an issue with the cartridge is not likely.Additionally, the qc fluid is not a likely cause of the event as all other assays that used fluid from the same cup all resulted as expected.The microslide incubator slot that contained the slide that produced the lower than expected result was also reviewed, and it was determined that other assays were resulting as expected form the same slot; therefore, an issue with that particular slot is unlikely.The signal read for the slide in question was abnormally low compared to what is normally expected for crea at the concentration of the l2 qc fluid as mentioned in the complaint investigation, which further supports an issue with the single slide.Historical quality control results were provided for vitros crea reagent lot 1519-3490-8161; however the baseline mean and sd was not provided for comparison, therefore a definitive determination cannot be made in regards to performance.The qc appears to be precise when comparing to the ortho performance verifier assay sheet sd¿s at a similar concentration.Additionally, there are not any out of range sd flags continually posting from the historical qc from e-connectivity, indicating that the qc was likely acceptable.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 1519-3490-8161.A vitros crea within run precision test was not performed, however an issue with the vitros 5600 integrated system is unlikely as all other assays were performing as expected, in addition to all other vitros crea results resulting as expected.

Event Description

A customer obtained a non-reproducible, lower than expected creatinine (crea) result from a non-vitros (randox) quality control (qc) fluid when tested using vitros chemistry products crea slides lot 1519-3490-8161 on a vitros 5600 integrated system.Randox l2 qc result <13.260 umol/l vs.The expected result of 184.0 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros crea result occurred on a non-vitros control fluid.There has been no allegations of actual patient harm as a result of this event, however the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected.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: 9503492
• MDR Text Key: 214630137
• Report Number: 1319809-2019-00125
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/20/2019

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: 09/01/2020
• Device Catalogue Number: 6802584
• Device Lot Number: 1519-3490-8161
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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