MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number 6802301

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/02/2023

Event Type  malfunction  

Event Description

A customer contacted the (b)(6) center (tsc) to report non-reproducible, higher and lower than expected troponin i es (tropi es) results were obtained from two different patient samples and a lower than expected vitros tropi es result was obtained when a non-vitros (biorad) qc fluid qc was processed using vitros tropi es lot 4830 on the same vitros (b)(4) integrated system.Patient 1, result of 1.132 ng/ml versus the expected results of <0.012 ng/ml patient 2, result of < 0.012 ng/ml versus the expected results of 1.206, 1.189 and 1.27 ng/ml biorad lot 67686 level 1 result of <0.012 ng/ml versus the pi mean of 0.102 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected result for patient 1 and the non-reproducible, lower than expected result for patient 2 were reported from the laboratory, however, corrected reports for each patient were issued and the customer indicated no patient treatment was altered, initiated or stopped based on the erroneous vitros tropi es results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to (b)(6) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation has determined that non-reproducible, higher and lower than expected troponin i es (tropi es) results were obtained from two different patient samples and a lower than expected vitros tropi es result was obtained when a non-vitros (biorad) qc fluid qc was processed using vitros tropi es lot 4830 on the same vitros (b)(4) integrated system.A definitive cause of the event was not established.A vitros tropi es lot 4830 reagent issue is an unlikely contributor to the event as historical qc results leading up to the event indicated acceptable vitros tropi es lot 4830 reagent performance.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagent lot 4830 at, or below the url concentration of 0.034 ng/ml cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product tropi es lot 4830.An instrument issue is an unlikely contributor to the event, as a sag test indicated acceptable instrument performance around the time of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer is not following the sample collection device manufacture¿s recommendation for sample centrifugation.In addition, the samples for the patients were not centrifuged between testing events and the h index for the samples were elevated suggested the samples were hemolyzed.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.It is possible the samples for patient 1 and patient 2 were run in place of one another in error as a result of patient sample mix up, owing to the discordant, non-reproducible results for the patients, however this could not be confirmed.In addition, pre-analytical handling of the biorad qc is a possible contributor to the lower than expected vitros tropi es result of <0.012 ng/ml from biorad level 1 qc testing.The customer suggested operators within the laboratory did not properly mix the contents of the vial prior to pipetting the qc fluid and processing the qc sample on the vitros instrument.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tropi es.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16261726
• MDR Text Key: 308502452
• Report Number: 3007111389-2023-00010
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: 10758750002504
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 6802301
• Device Catalogue Number: 6802301
• Device Lot Number: 4830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1