MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 853 6195

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that false positive vitros rub g results were obtained from a single patient sample when tested using vitros rub g lot 2210 on a vitros 5600 integrated system.A definitive assignable cause of the event was not established.A vitros rub g lot 2210 reagent issue cannot be ruled out as a contributor to the event.There was insufficient quality control data to verify vitros rub g reagent assay performance and the customer used a quality control fluid not recommended by ortho for use to verify vitros rub g performance a day prior to the event.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros rub g lot 2210.Additionally, an instrument issue cannot be ruled out as a contributor to the event, as precision testing was not conducted to verify the performance of the vitros 5600 integrated system.The customer was not following the manufacturer¿s recommendations for collection device handling.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 sample, although this could not be confirmed.A patient sample handling and storage issue cannot be ruled out as a contributor to the event.The patient sample was stored interchangeably between 2-8 c and -20 c storage since collection on (b)(6) 2020 and the false positive vitros rub g results that were obtained on (b)(4) 2020 and (b)(4) 2020 respectively, meaning the sample was outside the recommended storage.The vitros rub g instructions for use states that serum and plasma samples may be stored for up to 7 days at 2¿8 °c and to avoid repeated freeze-thaw cycles.Interference from a non-specific antibody has been ruled out as a contributor to the event, as the vitros rub g result from testing using a non-specific antibody blocking tube (nabt) was similar to the initial, untreated vitros rub g result for the patient.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) ortho technical solutions center (tsc) to report false positive vitros rubella igg (rub g) results from a single patient sample when tested using vitros rub g lot 2210 on a vitros 5600 integrated system.Vitros rub g results of 65.782 and 65.052 iu/ml (positive) versus the expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The positive vitros rub g results for the patient were not reported from the laboratory.The vitros rub g results were not used to aid in diagnosis of rubella infection but were generated during validation testing.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10650187
• MDR Text Key: 249813237
• Report Number: 3007111389-2020-00147
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/08/2020

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: 11/12/2020
• Device Catalogue Number: 853 6195
• Device Lot Number: 2210
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• 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