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

Catalog Number 6801322

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected, (b)(6) vitros hepatitis b surface antigen (hbsag) results were attained from a non-vitros biorad virotrol i (b)(6) control fluid using vitros immunodiagnostic products hbsag reagent lot 8561 on a vitros xt7600 integrated system.The assignable cause of the event was not established.An issue with the biorad virotrol i quality control fluid cannot be ruled out as a contributor to the event as there were no issues with vitros or other non-vitros quality control results when tested using vitros hbsag reagent lot 8561.Additionally, user error cannot be ruled out as a contributor to the event.It is possible that the customer was using an expired quality control fluid, not handling the quality control fluid correctly or not running the intended class of biorad quality control fluids although this could not be confirmed.The lower than expected vitros hbsag result of (b)(6) was likely due to fluid mix up, the fluid tested was most likely the biorad viroclear quality control fluid, however, this was not confirmed.An issue with vitros hbsag lot 8561 is an unlikely contributor to the event, as vitros hbsag quality control results for other fluids were within acceptable guidelines.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hbsag lot 8561.There was no evidence to suggest an instrument malfunction contributed to the event.However, as no precision testing was conducted on the vitros xt 7600 integrated system around the time of the event, an instrument issue cannot be entirely ruled out as a contributor to the event.

Event Description

A customer reported (b)(6) vitros hepatitis b surface antigen (hbsag) results obtained from a non-vitros (biorad) (b)(6) control fluid using vitros immunodiagnostic products hbsag reagent on a vitros xt7600 integrated system.Biorad virotrol i quality control results of (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The (b)(6) vitros hbsag results were obtained from a non-patient quality control fluid.The customer did not give any indication that patient results had been affected.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There have been no allegations of patient harm as a result of this event.This report is number 3 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

Event Description

Four supplemental emdr created to correct the date of event in the following trackwise records: emdr (b)(4) (3007111389-2020-00004), emdr (b)(4) (3007111389-2020-00005), emdr (b)(4) (3007111389-2020-00006), and emdr (b)(4) (3007111389-2020-00007).The above emdrs were sent to the fda on 10 january 2020.The date of event was erroneously entered as (b)(6) 2020 in field b3 of the emdrs.The correct date of the event is (b)(6) 2019.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 9575248
• MDR Text Key: 223664434
• Report Number: 3007111389-2020-00006
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 01/08/2020
• Device Catalogue Number: 6801322
• Device Lot Number: 8561
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1