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

Catalog Number 1896836

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected vitros ck-mb result was obtained from a patient sample when tested using vitros ck-mb reagent pack lot 2890 on a vitros 5600 integrated system.A vitros ck-mb lot 2890 reagent issue cannot be ruled out as a contributor to the event, as there were limited qc results available leading up to the event to verify the performance of the vitros ck-mb lot 2890 reagent.Diagnostic precision testing indicated acceptable performance of the vitros 5600 integrated system following the event, however, as no diagnostic precision testing was performed on the date of the event ((b)(6) 2021), a transient instrument issue cannot be completely ruled out as a contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determined if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Additionally, the sample viscosity had changed between vitros ck-mb runs.The viscosity value for the first run was 1.66 (vitros ck-mb result of 26.84 ng/ml) and the viscosity value for the repeat run was 2.14 (vitros ck-mb result of 2.73 ng/ml).Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Heterophilic interference is an unlikely contributor to the event, as further investigational testing using a heterophilic blocking tubes provided concordant results with the expected vitros ck-mb results for the patient.Patient sample mix up is an unlikely contributor to the event, as repeat vitros ck-mb testing immediately after the non-reproducible, higher than expected vitros ck-mb result was metered from the same tray and cup.A definitive assignable cause was not determined.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 2890.Email address for contact office is (b)(4).

Event Description

The investigation determined that a non-reproducible, higher than expected vitros ck-mb result was obtained from a patient sample when tested using vitros ck-mb lot 2890 on a vitros 5600 integrated systems.Vitros ck-mb result of 26.8 ng/ml versus the expected results of 2.73 and 3.23 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 non-reproducible, higher than expected vitros ckmb result was not reported from the laboratory and 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).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11807897
• MDR Text Key: 265023941
• Report Number: 3007111389-2021-00064
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: 1896836
• Device Lot Number: 2890
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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