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

Catalog Number 1896836

Device Problem High Test Results (2457)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros ckmb results were obtained from cliniqa quality control lot#: 2005075 processed on a vitros 5600 integrated system.The assignable cause of the event was not determined as inventory of ckmb lot 2821 was depleted.A review of historical cliniqa qc data with vitros ckmb lot 2821 indicated precision issues on all levels of control.A within run precision test was processed using cliniqa controls and acceptable precision and accuracy results were obtained indicating the vitros ckmb lot 2821 in combination with the vitros 5600 system was performing as expected at the time of precision testing.This would suggest a potential issue with day to day storage and handling of qc fluids but this was not confirmed.Therefore, pre-analytical qc fluid handling and storage could not be ruled out as a potential contributing factor to this event.A complaint review found no additional complaints for qc high or precision issues using this ckmb lot.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros ckmb lot#: 2821.Email address for contact office above is (b)(6).

Event Description

The customer reported that higher than expected vitros ckmb results were obtained from cliniqa quality control lot #: 2005075 processed on a vitros 5600 integrated system.Cliniqa level 1 = 4.82, 4.85, 4.86, 4.81, 4.71 versus expected 3.03 ng/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 customer did not process ckmb testing on patient samples since qc was unacceptable.However, the investigation cannot conclude that patient sample test results would not be affected if the event were to recur undetected.There was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK
• 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; 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: 11002410
• MDR Text Key: 222023725
• Report Number: 3007111389-2020-00203
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: RQ
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2021
• Device Catalogue Number: 1896836
• Device Lot Number: 2821
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• 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