MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number 1882208

Device Problem High Test Results (2457)

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

Event Date 05/22/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected calcium results were obtained from a non-vitros biorad quality control (qc) fluid and lower than expected calcium results were obtained from a vitros performance verifier (pvii) fluid using vitros chemistry products ca slides lot 0348-0605-4990 on a vitros xt3400 chemistry system.The assignable cause of the higher than expected biorad results is due to a suboptimal calibration.The cause of the suboptimal calibration is likely due to incorrect reconstitution of the cal kit 1 calibrator fluids, although this was not confirmed.All results were obtained on calibrations that were determined to have atypical parameters when compared to expected database values.When the calibrations with acceptable parameters were put into use, acceptable results were obtained for the biorad qc.The customer is not following correct fluid handling protocol for cal kit 1.The customer lets vials thaw from 30 mins to one hour from the freezer, reconstitutes, then lets them sit out for an hour.It is unknown what amount was used to reconstitute, or if the customer mixed the fluid while it was reconstituting.Per the vitros cal kit 1 instructions for use (ifu), the vials should thaw for approximately 60 minutes at room temperature from the freezer, then 3.0 ml of diluent is to be used to reconstitute each vial.The vials should then reconstitute for 30 minutes, with occasional inversion to mix the contents.The customer is not following ifu instructions as they are not always letting the vials thaw properly for reconstitution, and then are letting the vials sit for an extended period at room temperature following reconstitution.(b)(6).

Event Description

The investigation has determined that higher than expected calcium results were obtained from a non-vitros biorad quality control (qc) fluid using vitros chemistry products ca slides lot 0348-0605-4990 on a vitros xt3400 chemistry system.Biorad lot 56631 vitros ca results of 9.04, 9.03, 10.23, and 9.93 vs the baseline mean of 6.30.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros ca results were obtained from a non-vitros quality control fluid and no results were reported from the laboratory.However, the investigation could not rule out that patient results would not be affected if the event were to recur undetected.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).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 12041419
• MDR Text Key: 265179853
• Report Number: 1319808-2021-00010
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: 1882208
• Device Lot Number: 0190
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• 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