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

Catalog Number 6801812

Device Problem False Positive Result (1227)

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

Event Date 11/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that false reactive vitros ahavm lot 5480 and lot 5520 results were obtained for samples from a single patient when tested on two vitros 3600 immunodiagnostic systems.Additionally, false reactive vitros ahavt lot 5410 results were obtained from the same samples for the patient when tested on the same vitros 3600 immunodiagnostic systems.The results were discordant when compared to a non-vitros (biorad) hav igm pcr result for the patient which did not suggest acute hepatitis a infection.A definitive cause of the false reactive vitros ahavm and ahavt results was not established.The event was isolated to samples from a single patient.Sample specific interference cannot be ruled out as a contributor to the event.It is possible that an interferent that affects the vitros ahavm and vitros ahavt reagent assays contributed to the event, however, this could not be confirmed, as further investigational testing to rule out an interferent was not conducted when requested.The patient has cancer and undergoes chemotherapy.It is possible chemotherapy or medication taken by the patient interferes with the vitros ahavm or vitros ahavt testing, but this could not be confirmed.A vitros ahavm (lot 5480 and lot 5520) or vitros ahavt (lot 5410) reagent issue is an unlikely contributor to the event, as historical qc results 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 ahavm lot 5480, vitros ahavm lot 5520 or vitros ahavt lot 5410.There was no indication of a vitros instrument malfunction and the vitros ahavm and vitros ahavt results for the patient were reproducible across both instruments, therefore an instrument issue is an unlikely contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.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.Email address for contact office is (b)(6).

Event Description

A customer obtained discordant false reactive vitros ahavm lot 5480 and lot 5520 results for samples from a single patient when tested on two vitros 3600 immunodiagnostic systems.Additionally, discordant false reactive vitros ahavt lot 5410 results were obtained from the same samples for the patient when tested on the same vitros 3600 immunodiagnostic systems.The results were discordant when compared to a non-vitros (biorad) hav igm pcr result for the patient which did not suggest acute hepatitis a infection.Vitros ahavm results of 2.45, 2.42, 2.41, 2.52, 2.53, 2.80, 2.74, 2.70, 2.63, 2.94, 2.76, 2.79, 2.82, 2.71, 2.64, 2.59, 2.61, 2.66 and 2.62 s/c (reactive) versus the expected result of non-reactive.Vitros ahavt results of 0.10, 0.10, 0.09, 0.09, 0.09, 0.08, 0.08, 0.07, 0.07, 0.11 and 0.09 s/c (reactive) versus the expected result of non-reactive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The reactive vitros ahavm and vitros ahavt results were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12974347
• MDR Text Key: 290283917
• Report Number: 3007111389-2021-00182
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: 6801812
• Device Lot Number: 5520
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1