MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 TOTAL REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6199922

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a false reactive vitros cov2tot result was obtained when a level 1 cov2tot qc fluid was processed using vitros cov2tot reagent lot 0380 on a vitros eci immunodiagnostic system.A definitive cause of the event was not established.The event occurred as part of an internal vitros cov2tot lot 0100 qc post-expiry stability test event.A possible cause of the issue is the cov2tot lot 0100 qc fluid which had expired prior to testing.However, additional cov2tot results obtained during the same post-expiry qc fluid test event were acceptable.A vitros cov2tot reagent lot 0380 reagent issue is an unlikely contributor to the event, as the remaining results from vitros cov2tot lot 0100 qc fluid testing were acceptable.Additionally, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0380.An instrument issue cannot be ruled out as a contributor to the event, as no testing was undertaken to confirm the performance of the instrument.Additionally, the false reactive result was isolated to one instrument and additional qc results obtained from three different instruments were all acceptable.It is possible qc fluid mix up occurred, with the vitros cov2tot lot 0100 level 2 (reactive) fluid run in error instead of the non-reactive level 1 qc fluid, however, this could not be confirmed.Qc fluid material contamination cannot be ruled out as a contributor to the event.It was not determined if all testing conducted on (b)(6)2021 was from the same qc fluid bottle/aliquot.Acceptable results were obtained when fresh qc material was used as part of repeat testing on 29 march 2021.Email address for contact office is (b)(6).

Event Description

An ortho clinical diagnostics quality engineer (qe) reported a false reactive anti-sars-cov-2 total (cov2tot) result when a vitros cov2tot non-reactive quality control (qc) fluid was processed during internal post-expiry stability testing using vitros cov2tot lot 0380 in combination with a vitros eci immunodiagnostic system.Vitros cov2tot = 1.68 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 on patient samples.The vitros cov2tot false reactive result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 TOTAL 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: 11716790
• MDR Text Key: 267279231
• Report Number: 3007111389-2021-00053
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: 6199922
• Device Lot Number: 0380
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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