MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS IGA REAGENT; IN VITRO DIAGNOSTICS

Catalog Number 6801732

Device Problem High Test Results (2457)

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

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros iga results were obtained from several different patient samples using vitros chemistry products iga reagent, lot 1503-10-7115 on a vitros 4600 chemistry system.A definitive assignable cause could not be concluded.Based on historical quality control results, an issue with vitros iga reagent lot 1503-10-7115 could not be ruled out as a contributing factor of the event.There was some possible imprecision seen for the reagent with the mas level 2 control fluid.However, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros iga reagent lot 1503-10-7115.Furthermore, vitros protein performance verifiers tested by the customer using vitros iga reagent lot 1503-10-7115 on the vitros 4600 chemistry system yielded acceptable results.Marker precision testing run on the vitros 4600 chemistry system was within acceptable guidelines.However, an instrument issue cannot be ruled out as a contributing factor to the event as within run precision testing was not conducted at the time that the higher than expected patient sample results were attained.Pre-analytical sample processing could not be ruled out as a contributing factor.The customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Improper protocol by the user could not be ruled out as a contributing factor to the event.No calibration events were found to have taken place during a three-month timeframe during which the higher than expected patient sample results were obtained.Several reagent expired (re) codes were also found in econn data for several patient samples tested by the site.The customer also had stored and retested a patient sample that had been stored in the refrigerator longer than the specimen storage stability length.After the calibration event on (b)(6) 2019, the patient results tested on the vitros 4600 chemistry system were deemed to be acceptable by the customer.The higher than expected vitros iga results were reported from the laboratory, however a physician questioned several of the results.No treatment was altered, initiated or stopped based upon the reported results.There was no allegation of patient harm as a result of this event.

Event Description

A customer contacted the ortho technical solutions center (tsc) to report higher than expected vitros iga results obtained from multiple patient samples using vitros chemistry products iga reagent on a vitros 4600 chemistry system.The samples were from patients known to be historically low iga patients.Patient 1 sample vitros iga result of 70 versus an expected historical result of <5; patient 2 sample vitros iga result of 70 versus an expected historical result of <5; patient 3 sample vitros iga result of 74 versus an expected historical result of 8; patient 4 sample vitros iga result of 99 versus an expected historical result of 20; patient 5 sample vitros iga result of 69 versus an expected historical result of <5; patient 6 sample vitros iga result of 85 versus an expected historical result of 11; patient 7 sample vitros iga result of 69 versus an expected result of <5; patient 8 sample vitros iga result of 85 versus an expected result of 8; patient 9 sample vitros iga result of 75 versus an expected historical result of 7; patient 10 sample vitros iga result of 68 versus an expected historical result of <5; patient 11 sample vitros iga result of 68 versus an expected result of <5.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 iga results were reported from the laboratory, however a physician questioned several of the results.No treatment was altered, initiated or stopped based upon the reported results.There was no allegation of patient harm as a result of this event.This report is number 5 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.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS IGA REAGENT
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8861863
• MDR Text Key: 216609918
• Report Number: 1319808-2019-00025
• Device Sequence Number: 1
• Product Code: CFN
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Catalogue Number: 6801732
• Device Lot Number: 1503-10-7115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• 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