MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS BRAHMS PCT REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6197735
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros immunodiagnostics products b¿r¿a¿h¿m¿s pct reagent pack (pct) results were obtained from 10 different patient samples and 2 different levels of vitros pct lot 0320 controls tested on a vitros 3600 immunodiagnostic system.The assignable cause of the lower than expected results was a reagent pack related issue.The affected results were isolated to a single reagent pack.The issue with the affected reagent pack is unknown, as it is assumed the affected reagent pack was discarded by the customer and no further investigation was possible.Except for the affected reagent pack, there was no indication that vitros pct reagent lot 0350 was not performing as intended, based on historical quality control results.In addition, there is no indication the vitros 3600 immunodiagnostic system malfunctioned as acceptable vitros pct performance was obtained using alternate vitros pct lot 0350 reagent packs prior to, and after the event.The event is isolated to reagent pack id (b)(6).
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros immunodiagnostics products b¿r¿a¿h¿m¿s pct reagent pack (pct) results were obtained from 10 different patient samples and 2 different levels of vitros pct lot 0320 controls tested on a vitros 3600 immunodiagnostic system.Patient sample 1 vitros pct result of <0.030 ng/ml vs.The expected result of 8.76 ng/ml patient sample 2 vitros pct result of 0.226 ng/ml vs.The expected result of 2.25 ng/ml patient sample 3 vitros pct result of 0.062 ng/ml vs.The expected result of 9.28 ng/ml patient sample 5 vitros pct result of <0.030 ng/ml vs.The expected result of 5.59 ng/ml patient sample 6 vitros pct result of <0.030 ng/ml vs.The expected result of 1.22 ng/ml patient sample 7 vitros pct result of <0.030 ng/ml vs.The expected result of 3.14 ng/ml patient sample 9 vitros pct result of 0.037 ng/ml vs.The expected result of 4.31 ng/ml patient sample 12 vitros pct result of <0.030 ng/ml vs.The expected result of 3.77 ng/ml patient sample 13 vitros pct result of <0.030 ng/ml vs.The expected result of 12.8 ng/ml patient sample 14 vitros pct result of 0.100 ng/ml vs.The expected result of 0.61 ng/ml vitros pct control lot 0320 level 1 results of <0.03, <0.03 and <0.03 pg/ml vs.The expected result of 0.40 pg/ml vitros pct control lot 0320 level 3 results of <0.03, <0.03 and <0.03 pg/ml vs.The expected result of 52.0 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros pct patient sample results were reported outside of the laboratory, however, corrected reports were issued.No treatment was started, stopped or altered based on the lower than expected vitros pct results reported.There was no 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 BRAHMS PCT REAGENT PACK
• Common Device Name: 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: 17627054
• Report Number: 3007111389-2023-00140
• Device Sequence Number: 15339847
• Product Code: PMT
• UDI-Device Identifier: 10758750033287
• UDI-Public: 10758750033287
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Catalogue Number: 6197735
• Device Lot Number: 0350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown