MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK; IN VITRO DIAGNOSICS

Catalog Number 1912997

Device Problem High Test Results (2457)

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

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected quality control results were obtained from non-vitros biorad quality control lot 41000 processed using vitros tsh reagent lot 6360 in combination with a vitros 5600 integrated system.The assignable cause of the event was not determined.The higher than expected qc results were obtained post calibration of a new tsh lot 6360.The biorad qc fluids were not a likely contributor the event as they were performing as expected on other microwell assays as well as two alternate tsh lots.The customer calibrated multiple times using two tsh reagent packs.While the calibrations passed, the signals were consistently on the low end of the acceptable range suggesting suboptimal calibrations.The cause of the suboptimal calibrations was unknown but potential contributors include an issue with the calibrator fluids and/or an unknown issue with the tsh reagent packs at the customers site.A complaint review did not identify an ongoing vitros lot 6360 issue.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tsh lot 6360.There was no indication that the vitros 5600 integrated malfunctioned.However, as no precision testing was conducted around the time of the event to verify instrument performance, an instrument issue cannot be ruled out as a contributor to the event.(b)(4).

Event Description

The customer reported that higher than expected quality control results were obtained from non-vitros biorad quality control lot 41000 processed using vitros tsh reagent lot 6360 in combination with a vitros 5600 integrated system.Biorad level 1 = 0.952, 0.972, 0.927, 0.946, 0.939 versus expected 0.70 miu/l.Biorad level 3= 38.72, 39.54, 38.18, 37.77, 38.0, 38.75, 37.86, 36.49 versus expected 27.5 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer did not process routine patient testing on this vitros tsh lot 6360 as quality control results were not acceptable.There were no allegations of patient harm as a result of the event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN VITRO DIAGNOSICS
• 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11028034
• MDR Text Key: 251887722
• Report Number: 3007111389-2020-00211
• Device Sequence Number: 1
• Product Code: JLW
• 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: 12/17/2020

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: 07/19/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6360
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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