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

Catalog Number 6801925

Device Problem High Test Results (2457)

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

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros ahbs result was obtained when the customer was processing a non-vitros (biorad) quality control fluid on a vitros 5600 integrated system.An assignable cause of the higher than expected vitros ahbs result was not determined.An acceptable diagnostic precision test indicated acceptable instrument performance.However, as a precision test was not conducted on the instrument at the time of the event (09 march 2020) an instrument issue cannot be entirely ruled out as a contributor to the event.A vitros ahbs reagent issue is an unlikely contributor to the event as historical quality control results were within acceptable guidelines leading up to the event.The higher than expected vitros ahbs result was obtained on reagent pack 219 of vitros ahbs lot 8300 and the customer used an alternative reagent pack from lot 8300 to conduct further vitros ahbs tests.An issue with reagent pack 219 of vitros ahbs lot 8300 is an unlikely contributor to the event as quality control results on this reagent pack were within acceptable guidelines.A vitros ahbs lot 8300 reagent issue cannot be entirely ruled out as a contributor to the event as the customer did not process quality control fluids to verify reagent performance on a regular basis leading up 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 ahbs lot 3800.

Event Description

A customer contacted the ortho (ortho clinical diagnostics) technical solutions centre (tsc) to report higher than expected vitros anti-hbs (ahbs) results when testing non-vitros (biorad) quality control fluids on a vitros 5600 integrated system.Biorad viroclear result of 15.945 and 230.143 miu/ml (reactive) 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 on patient samples.The higher than expected vitros ahbs results were obtained from non-patient fluids.No patient sample results were affected around the time of the event and 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) / ivd 465824.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE 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: 9930341
• MDR Text Key: 207391048
• Report Number: 3007111389-2020-00034
• Device Sequence Number: 1
• Product Code: LOM
• 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: 04/06/2020

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: 06/01/2020
• Device Catalogue Number: 6801925
• Device Lot Number: 8300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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