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

Catalog Number 6802301

Device Problems High Readings (2459); Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher and lower than expected vitros tropi es (troponin i es) results were obtained from patient samples from five different patients when tested on a vitros 5600 integrated system.The assignable cause could not be determined.Within run precision testing for instrument 56001580 was within expectations, indicating the instrument was performing as expected.There was no pre-service precision performed for instrument 56001583.Service actions were completed by an ortho field engineer including refurbishing the incubator, performing adjustments, and replacing the cooler.Post service precision testing was within expectations.The service actions returned the instrument to expected operation.An instrument related issue cannot be ruled out as a contributing factor.The customer is not following the sample collection device manufacture¿s recommendation for sample centrifugation, therefore, improper pre-analytical sample handling cannot be ruled out as a contributing factor to the event.It is possible that cellular debris was present in the affected samples, although, this could not be confirmed.The historical tropi es quality control performance is within expectations for both instruments.The level 1 control does not adequately evaluate performance of the vitros tropi es reagent for a sample with troponin i concentrations < url (0.034 ng/ml).A vitros tropi es reagent issue cannot be entirely ruled out as a contributing factor.In addition, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros trop i es reagent lot 3220.

Event Description

A customer obtained non-reproducible, higher and lower than expected vitros tropi es (troponin i es) results from patient samples from five different patients when tested on a vitros 5600 integrated system.Patient 1 trop i es result of 0.019 ng/ml vs.The expected result of 0.057 ng/ml, patient 2 trop i es result of 0.045 ng/ml vs.The expected result of <0.012 ng/ml, patient 3 trop i es result of 0.186 ng/ml vs.The expected result of <0.012, 0.017 ng/ml, patient 4 trop i es result of 0.188 ng/ml vs.The expected result of <0.012, <0.012, <0.012 ng/ml, patient 5 trop i es result of <0.012 ng/ml vs.The expected result of 0.409, 0.404, 0.392 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, higher and lower than expected vitros tropi es patient sample results were reported from the laboratory.Although the result for patient 2 does not meet vitros tropi es numeric potential health and safety criteria, there was treatment based on the higher than expected result.The patient was placed on a heparin drip.It is not known if the treatment was based solely on the higher than expected tropi es result.Per consultation with an ortho medical safety officer, patients on iv heparin are normally under close observation and monitoring for bleeding.If the patient did not experience any serious side effect during the hospital stay, serious long term health risk is unlikely.The customer reported changes in treatment for patient 3 and patient 4 based on the unexpected results.The specifics of these changes in treatment were not provided.It is not known if the treatment was based solely on the unexpected tropi es results.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 8579842
• MDR Text Key: 203706044
• Report Number: 3007111389-2019-00078
• Device Sequence Number: 1
• Product Code: MMI
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2019
• Device Catalogue Number: 6802301
• Device Lot Number: 3220
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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
• Patient Outcome(s): Other