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

Catalog Number 1912997

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/19/2015

Event Type  malfunction  

Event Description

The customer observed lower than expected vitros tsh results for a single patient sample when using vitros tsh reagent on a vitros 5600 integrated system.Vitros tsh patient results: 0.47, 0.48 miu/l vs.Expected 1.35 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.The patient result was reported to a physician who requested that the sample be repeat tested at an alternate site.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results for a single patient sample were obtained when using vitros tsh reagent on a vitros 5600 integrated system.Root cause for the event could not be determined; however, pre-analytical sample handling and/or a sample interferent could not be ruled out as contributing factors.The investigation found no evidence to suggest the vitros tsh reagent or vitros 5600 system had malfunctioned.

• Brand Name: VITROS IMMUNODIAGNOSTICS 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: 4703983
• MDR Text Key: 5726186
• Report Number: 3007111389-2015-00089
• Device Sequence Number: 1
• Product Code: JLW
• 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: 04/17/2015

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: 07/23/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1