MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN-VITRO DIAGNOSTICS

Catalog Number 8568040

Device Problem High Test Results (2457)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros phyt quality control result and a higher than expected vitros crbm quality control result were obtained from a vitros therapeutic drug monitoring performance verifier processed using vitros chemistry products phyt slides lot 2621-0177-0750 and vitros chemistry products crbm slides lot 3903-0112-9906 on two different vitros 4600 chemistry systems.The assignable cause of the events is suboptimal calibrations most likely caused by turbidity of the fluids of the vitros cal kit 9 lot 0959 and 0969 in use at the time of the event.The parameters for the initial vitros phyt and crbm calibrations were atypical compared to the database values.After recalibration of both assays using an alternate lot of vitros cal kit 9 that were not turbid, acceptable post calibration qc results were obtained.Ortho currently has an investigation open, complaint investigation 496760, for turbid and discolored fluid in vitros cal kit 9 lots 0959, 0969, 0970 and 0991 as well as vitros tdm i x8115 and tdm ii y8116.As vitros phyt lot 2621-0177-0750 and vitros crbm lot 3903-0112-9906 were new reagent lots for the customer at the time of the events, no historical qc results were available for evaluation.Therefore, a reagent related issue could not be entirely ruled out as a contributor of the events.Although no precision testing was performed on the vitros 4600 systems, an instrument related issue is not a likely contributor of the events as acceptable results were obtained on both instruments without any known actions being performed on the instruments other than recalibration of the assays.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros phyt reagent lot 2621-0177-0750 or vitros crbm reagent lot 3903-0112-9906.Email address for contact office is (b)(4).

Event Description

The investigation determined that a higher than expected vitros phyt quality control result and a higher than expected vitros crbm quality control result were obtained from a vitros therapeutic drug monitoring performance verifier processed using vitros chemistry products phyt slides lot 2621-0177-0750 and vitros chemistry products crbm slides lot 3903-0112-9906 on two different vitros 4600 chemistry systems.Vitros phyt lot 2621-0177-0750 on j1: vitros tdm ii lot y8116 result of 24.75 ug/ml vs the expected result of 14.1 ug/ml.Vitros crbm lot 3903-0112-9906 on j2: vitros tdm ii lot y8116 result of 13.703 ug/ml vs the expected result of 10.48 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected results were from a control fluid and were not reported outside of the laboratory.The customer confirmed that no patient samples were processed after the unexpected qc results were obtained.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two 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 number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12732888
• MDR Text Key: 279931019
• Report Number: 3007111389-2021-00140
• Device Sequence Number: 1
• Product Code: JIT
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 8568040
• Device Lot Number: 0969
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• 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