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

Catalog Number 6802301

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined, through a retrospective review of vitros troponin i es (tropi es) complaints, that a customer reported lower than expected vitros tropi es results on (b)(6) 2018 when processing cap proficiency samples on a vitros 3600 immunodiagnostic system.A definitive assignable cause could not be determined with the information provided.There is insufficient information documented to draw any conclusions regarding the performance of the reagent or instrument at the time of the event.Trend analysis performed by the complaint handling unit has not identified any quality issues with the vitros tropi es lot 2460.In addition, no details were provided regarding the handling and storage of the proficiency samples.It is unlikely any additional information can be obtained at this time to aid in the investigation of an assignable cause.

Event Description

A complaint was received on (b)(4) 2018 from a customer reporting lower than expected vitros troponin i es (tropi es) results when processing proficiency fluids on a vitros 3600 integrated system.Cr-2 vitros tropi es result 0.02 ng/ml versus expected vitros tropi es result 0.094 ng/ml.Cr-5 vitros tropi es result 0.03 ng/ml versus expected vitros tropi es result 0.125 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, however, the lower than expected vitros tropi es results were obtained when processing proficiency fluids.There has been no allegations of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES 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: 7971042
• MDR Text Key: 126096745
• Report Number: 3007111389-2018-00156
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2017
• Device Catalogue Number: 6802301
• Device Lot Number: 2460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• 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