MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS ECI IMMUNODIAGNOSTIC SYSTEM

Catalog Number 6801059

Device Problems Contamination (1120); Failure to Calibrate (2440)

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

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a failed calibration attempt of vitros ferritin reagent on the vitros eci analyzer occurred.The likely assignable cause of the unsuccessful calibration is contamination of the signal reagent (sr) in the reaction well.Residual dried signal reagent present on the outside of the sr probes can re-hydrate and alter the sr reaction causing suppressed light units within the well.After cleaning the sr dispense probes, an acceptable vitros ferritin calibration was obtained.User error regarding routine maintenance of cleaning the sr probe cannot be rule out as a contributing factor as no substantial evidence was presented indicating that maintenance was being performed.(b)(4).

Event Description

The customer obtained a failed calibration for vitros ferritin reagent lot 2260 while using the vitros eci immunodiagnostics system.Signal reagent probe contamination was observed.Biased results related to signal reagent probe contamination may lead to inappropriate physician action.There was no report that patient sample results were affected.There was no allegation of harm to patients as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS ECI IMMUNODIAGNOSTIC SYSTEM
• Type of Device: IMMUNODIAGNOSTIC SYSTEM
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10828638
• MDR Text Key: 226896324
• Report Number: 1319681-2020-00117
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6801059
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2002
• 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