MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 6801861

Device Problem False Negative Result (1225)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a false negative vitros anti-hiv 1 + 2 (ahiv1+2) result was obtained from non-vitros riqas proficiency fluids when using vitros immunodiagnostics products vitros ahiv1+2 reagent in combination with a vitros 5600 integrated system.A definite assignable cause of the event cannot be determined with the information provided.Sample handling and storage of the proficiency samples is not a contributor to the event as it was determined that the customer is following the riqas ifu recommendation for sample handling and storage.Therefore, improper sample handling and storage is not a contributor to the event.The customer did not provide the lot number of the vitros ahiv1+2 quality control (qc) fluid used to verify the performance of the vitros ahiv1+2 assay, however, a review of the customers qc results prior to the event fell in the appropriate vitros interpretation classification, indicating acceptable accuracy when using reagent lot 4260.Vitros ahiv1+2 reagent lot 4260 was calibrated on (b)(6) 2023 and subsequently calibrated on (b)(6) 2023 indicating all results processed after (b)(6) 2023 were obtained on an expired calibration.The event occurred on (b)(6) 2023, therefore, the false negative vitros ahiv1+2 result was processed on an expired calibration.There was no evidence of an instrument malfunction, however, as no diagnostic precision testing was conducted to verify the performance of the vitros 5600 integrated system, an instrument issue cannot be completely ruled out as a contributor to the event.The customer did not indicate that any unexpected vitros ahiv1+2 results were obtained for patient samples at the time of the event or over the course of the investigation and there are no reported allegations of patient harm, however, the investigation cannot rule out that patient samples were not, or would not be affected, if the event were to occur undetected.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a false negative vitros anti-hiv 1 + 2 (ahiv1+2) result was obtained from non-vitros riqas proficiency fluids when using vitros immunodiagnostics products vitros ahiv1+2 reagent in combination with a vitros 5600 integrated system.Riqas sample 1 result of 0.280 s/c vs.Expected result of 19.150 s/c biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The false negative vitros ahiv1+2 result was obtained from a non-patient fluid and 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 corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18092854
• MDR Text Key: 328769703
• Report Number: 3007111389-2023-00195
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2023
• Device Catalogue Number: 6801861
• Device Lot Number: 4260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1