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

Catalog Number 1912997

Device Problem High Test Results (2457)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros tsh result was obtained for a patient sample when tested on a vitros 5600 integrated systems.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tsh lot 5420 performance issue is not a likely contributor to the event.Analyzer performance is an unlikely contributor, however due to the delay between the event and the vitros tsh within-run precision test, an instrument issue cannot be completely ruled out.Improper pre-analytical sample handling may have contributed to this event as the customer is not following the sample collection device manufacturer¿s recommendation for sample centrifugation, although this cannot be confirmed.In addition, it is possible that an unknown patient sample interferent, could have contributed to the higher than expected result, although this could not be confirmed.

Event Description

The customer obtained a higher than expected vitros tsh result from a patient sample on a vitros 5600 integrated system.The tsh results are as follows: patient sample result of 7.88 miu/l vs.The expected result of 1.69 miu/l biased results of the direction and magnitude observed could lead to inappropriate physician action.The higher than expected result was reported outside of the laboratory.Treatment was not altered, initiated or stopped based upon the reported result.Ortho was not made aware of any patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4)/qerts reference id (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH 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: 7142728
• MDR Text Key: 96368529
• Report Number: 3007111389-2017-00212
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5420
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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