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

Catalog Number 8298671

Device Problem High Test Results (2457)

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

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected phenytoin (phyt) results were obtained from a single patient sample as well as a quality control fluid using vitros chemistry products phyt slides lot 2620-0173-7028 on two vitros 5600 integrated systems.The cause of the higher than expected qc results is unknown, but is likely related to improper fluid handling.The customer could not confirm that the qc was mixed properly on the days in question.Additionally, the customer dilutes their qc prior to running; per the instructions for use, there is no protocol for qc dilution.The most likely assignable cause for the higher than expected patient results is a sample related issue, likely due to improper pre-analytical sample handling protocol.The customer was not able to provide details on the sample appearance at the time of processing, however the sample showed elevated hemolysis that increased after the initial run of the sample on both systems.Per the phyt ifu, hemolyzed samples should not be used.The customer is not following the sample collection device manufacturer¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed by the customer.Based on historical quality control results, a vitros phyt lot 2620-0173-7028 performance issue is not a likely contributor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros phyt reagent lot 2620-0173-7028.Vitros phyt, vitros crmb, and vitros alkp within run precision testing was performed by the customer on both vitros 5600 integrated systems.The testing yielded results that were within acceptable guidelines, further indicating a reagent issue or an issue with the vitros 5600 integrated systems is unlikely.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected phenytoin (phyt) results obtained from a single patient sample using vitros chemistry products phyt slides on two vitros 5600 integrated systems.(b)(4).Patient sample result of 24.3 ug/ml vs.An expected result of 7.6 ug/ml mas chemtrak-h l3 control lot chu21113a results of 30.56 and 32.12 vs expected result of 221.14 ug/ml.(b)(4).Patient sample result of 23.1 ug/ml vs.An expected result of 7.6 ug/ml mas chemtrak-h l3 control lot chu21113a results of 32.77, 32.98, 32.10 and 29.67 vs expected result of 221.14 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The non-reproducible, higher than expected vitros phyt results were reported from the laboratory and a corrected report was issued.No treatment was initiated, altered or stopped based upon the initial reported results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 2 of 8 mdr¿s for this event.Eight (8) 3500a forms are being submitted for this event as 8 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT 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: 10321250
• MDR Text Key: 241556100
• Report Number: 1319809-2020-00071
• Device Sequence Number: 1
• Product Code: DIP
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2620-0173-7028
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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