MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN CALIBRATORS; IN-VITRO DIAGNOSTIC

Catalog Number 6801043

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that a lower than expected vitros myoglobin (myog) quality control (qc) result was obtained using a non-vitros (biorad) qc fluid in combination with a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined.Historical qc results for vitros myog lot 1321 were reviewed and were acceptable with respect to accuracy and precision.However, ortho has become aware of a calibrator stability issue post reconstitution and this issue is being investigated.There was also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, the customer did not perform a within run precision test when requested at the time of the event to definitively rule out an instrument issue.A definitive assignable cause of the event could not be determined.

Event Description

A customer obtained a lower than expected vitros myoglobin (myog) quality control (qc) result using a non-vitros (biorad) qc fluid in combination with a vitros 5600 integrated system.Vitros myog result of 57.902 ng/ml versus the package insert mean of 68.17 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros myog result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.Ortho has not been made aware of allegation of actual patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

Manufacturer Narrative

The actual product impacted by this event is the vitros immunodiagnostics products myoglobin calibrators, not the vitros immunodiagnostic products myoglobin reagent pack.Therefore, the brand name, common device name, catalogue # and unique device identifier have been corrected.Investigation into the root cause is still in progress, but the issue is linked to the stability of the vitros myoglobin calibrators post reconstitution by the user.Ortho has issued field action with the following instructions to the end user.1.Reconstitute the calibrators using 1.0 ml distilled water, as per current instructions.2.Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total).3, discard reconstituted calibrators after 4 hours.Ortho notified the fda¿s new york district office of this field action on 30 november 2018.

Event Description

This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN CALIBRATORS
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 8045583
• MDR Text Key: 128276828
• Report Number: 3007111389-2018-00168
• Device Sequence Number: 1
• Product Code: JIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Catalogue Number: 6801043
• Device Lot Number: 1321
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1