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

Catalog Number 6801042

Device Problem Low Test Results (2458)

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

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that lower than expected vitros myoglobin (myog) results were obtained from a biorad quality control (qc) fluid processed using vitros myog reagent in combination with a vitros 5600 integrated system.An assignable cause for the lower than expected qc results could not be determined.Although the customer is not following the guidelines per cl2018-262 which states that calibrators must be left out for a minimum of two hours following reconstitution prior to calibrating, the calibrations appear acceptable and do not show an elevated calibrator signal for the calibrations that the qc was run on which gave the lower than expected results.A reagent issue is not likely as qc was running closer to expectation on the customer¿s alternate analyzer for the same reagent and qc lot combination.The customer is no longer on the lot of reagent that produced the lower than expected results.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros myog lot 1440.A vitros tsh precision test was processed on the vitros 5600 integrated system, but a guideline was unable to be generated due to too few replicates.However, a total t4 precision test did pass successfully indicating the analyzer was operating as expected.

Event Description

A customer reported lower than expected results from a biorad quality control (qc) fluid obtained using vitros immunodiagnostics products myoglobin (myog) reagent on a vitros 5600 integrated system.Biorad qc lot 29880 l1 vitros myog results of 58.82, 56.52, 59.76, 57.96, 59.34, 58.17, 59.97 and 59.84 ng/ml vs biorad july peer mean 69.99 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 unexpected vitros myog results were generated from a qc fluid.However, the investigation could not conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report is number 2 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8920138
• MDR Text Key: 219605742
• Report Number: 3007111389-2019-00121
• Device Sequence Number: 1
• Product Code: DDR
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2019
• Device Catalogue Number: 6801042
• Device Lot Number: 1440
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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