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

Catalog Number 6802584

Device Problems High Readings (2459); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that non-reproducible, higher than expected creatinine results were obtained from samples from three different patients using vitros chemistry products crea slides lot 1519-3487-5358 on a vitros 5600 integrated system.The magnitude of bias of the vitros crea results meets potential health and safety criteria and the results are reportable.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros crea reagent lot 1519-3487-5358 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 1519-3487-5358.Vitros crea within run precision testing performed by the customer on the vitros 5600 integrated system was within ortho acceptable guidelines suggesting an instrument issue was not likely a contributing factor.However, because the precision testing was not completed around the time of the event, an issue with the vitros 5600 integrated system could not be entirely ruled out as a contributor to the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor of the event.It is unknown if the customer was 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.The higher than expected vitros crea results were reported from the laboratory.A physician questioned the results and corrected reports were later issued.No treatment was initiated, altered or stopped based on the higher than expected results and there have been no allegations of patient harm as a result of this event.

Event Description

On (b)(6) 2019, a distributor of product and application specialist on behalf of a customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report non-reproducible, higher than expected creatinine results obtained from samples from three different patients using vitros chemistry products crea slides on a vitros 5600 integrated system.The event occurred on (b)(6) 2019.Patient 1 sample result of 207.6 umol/l vs.The expected result of 93.4 umol/l.Patient 2 sample result of 245.4 umol/l vs.The expected result of 110.3 umol/l.Patient 3 sample result of 142.6 umol/l vs.The expected result of 63.5 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros crea results were reported from the laboratory.A physician questioned the results and corrected reports were later issued.No treatment was initiated, altered or stopped based on the higher than expected results and there have been no allegations 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.Complaint numbers (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: 9193102
• MDR Text Key: 214616917
• Report Number: 1319809-2019-00103
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 6802584
• Device Lot Number: 1519-3487-5358
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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