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

Catalog Number 6802301

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that non-reproducible, higher than expected vitros trop i es results were obtained from two patient samples processed on the vitros eciq immunodiagnostic system.The investigation could not determine a definitive assignable cause.Pre-service within-run vitros tropi es precision testing was not performed, therefore, an instrument related issue cannot be ruled out as contributing to the event.An ortho field engineer replaced the incubator shuttle and all adjustments.In addition, the wash station and tubing were replaced due to wear.Acceptable tropi es performance was obtained after service, however, it is unknown if the service actions taken mitigated an instrument issue that may have contributed to the event.Based on historical quality control results, a vitros tropi es reagent related issue is not a likely contributor to the event.However, the l1 control does not adequately evaluate performance of the vitros tropi es reagent for sample with troponin i concentrations < url (0.034 ng/ml), therefore, a reagent issue cannot be entirely ruled out as a contributing factor.Furthermore, pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

The customer observed non-reproducible, higher than expected, vitros tropi es results were obtained from two patient samples tested on a vitros eciq immunodiagnostic system.Patient 1 sample result of 0.573 ng/ml vs.The expected result of <0.012 ng/ml, patient 2 sample result of 0.108 ng/ml vs.The expected result of <0.012 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros tropi es results were not reported outside of the laboratory and there were no allegations of patient harm as a result of the event.This report is number two of two 3500a forms filed for this event, as two devices were affected.(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: 7570432
• MDR Text Key: 110592353
• Report Number: 3007111389-2018-00079
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2018
• Device Catalogue Number: 6802301
• Device Lot Number: 2840
• Other Device ID Number: 10758750002504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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