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

Catalog Number 6801925

Device Problem High Test Results (2457)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros (b)(6) results were obtained from different samples from the same patient processed using vitros (b)(6) reagent lot 3270 and lot 3280 on a vitros 3600 immunodiagnostic system.The most likely cause of this event is due to a non-specific antibody interference present in the patient sample.The testing of the patient sample treated with the non-specific antibody blocking tube (nabt) tube supports this, as it shows a large decrease in sample reactivity compared to the original untreated sample result.

Event Description

A customer obtained higher than expected vitros (b)(6) results from different samples from the same patient processed using vitros (b)(6) reagent lot 3270 and lot 3280 on a vitros 3600 immunodiagnostic system.On (b)(6) 2019- patient 1, sample 1 vitros (b)(6) positive result of 31.2 miu/ml versus expected <8.0 miu/ml (negative).On (b)(6) 2019- patient 1, sample 2 vitros (b)(6) positive result of 113 miu/ml versus expected <8.0 miu/ml (negative).On (b)(6) 2019- patient 1, sample 3 vitros (b)(6) positive result of >100 miu/ml versus expected <8.0 miu/ml (negative).Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros (b)(6) results were reported from the laboratory but were questioned by the physician.There was no change in treatment and ortho has not been made aware of any allegation of actual patient harm as a result of the event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 8873857
• MDR Text Key: 219479971
• Report Number: 3007111389-2019-00113
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/08/2019

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: 07/23/2019
• Device Catalogue Number: 6801925
• Device Lot Number: 3270
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• 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