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

Catalog Number 1612365

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros calcium (ca) results were attained from a non-vitros biorad quality control (qc) fluid using vitros chemistry products ca slides lot 0332-0585-2088 in combination with a vitros 350 chemistry system.Lower than expected unconjugated bilirubin results were attained from a vitros performance verifier (pv) fluid processed using vitros chemistry products bubc slides lot 0244-0426-2893 on a vitros 350 chemistry system.The assignable cause of the higher and lower than expected results is unknown.Multiple service actions were performed on the vitros 350 chemistry system including cleaning the reflectometer assembly, performing adjustments on the incubator/dispense path, incubator cm depth, and read sync; processing correction factors and running the static test.Additionally, calibrations of the vitros ca and bubc assays were performed after the service actions.Therefore, it is unknown if the cause is analyzer or calibration related.The field engineer (fe) did not process pre and post service precision runs, therefore, it is unknown how the analyzer was running prior to the service actions.Therefore, the analyzer cannot be fully confirmed or ruled out as a potential contributor to this event.Historical vitros ca qc showed unacceptable precision.Following the service actions and calibrations performed, the qc was as expected indicating that a vitros ca reagent lot performance issue is not a likely contributor to the event.Historical qc data was not available for vitros bu, however, the customer indicated that the direct bilirubin values were as expected since the service actions and calibrations were performed by the fe.Therefore, a vitros bubc reagent lot performance issue is not a likely contributor to the event.

Event Description

A customer reported higher than expected vitros calcium (ca) results obtained from a non-vitros biorad quality control (qc) fluid processed using vitros chemistry products ca slides in combination with a vitros 350 chemistry system.The customer also reported lower than expected unconjugated bilirubin results obtained from a vitros performance verifier (pv) fluid processed using vitros chemistry products bubc slides on a vitros 350 chemistry system.Vitros pvii lot j6978 bu results of 6.6, 6.7, 6.7 and 6.7 mg/dl versus an expected result of 10.0 mg/dl.Biorad lot 45830 l1 ca results of 11.11 and 11.0 mg/dl versus an expected result of 6.16 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.Both the lower and higher than expected results occurred on qc fluids only, and the customer stopped processing patients for the affected assays after obtaining the lower and higher than expected qc results.There was no allegation of patient harm as a result of this event.This report is number 3 of 6 mdr¿s for this event.Six (6) 3500a forms are being submitted for this event as 6 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS BUBC 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: 9592990
• MDR Text Key: 214633242
• Report Number: 1319809-2020-00003
• Device Sequence Number: 1
• Product Code: CIG
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 1612365
• Device Lot Number: 0244-0426-2893
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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