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 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros tsh results were obtained from vitros quality control samples.The investigation was unable to determine an assignable cause.The results were generated during a product performance investigation study.Further investigation into lower than expected qc results with vitros tsh reagent lot 5480 is ongoing.

Event Description

The customer obtained unexpected tsh results from vitros quality control samples using vitros immunodiagnostic products tsh reagent on a vitros 3600 immunodiagnostic system and a vitros eci immunodiagnostic system.Ttc l1 lot 0660 control results of 0.026, 0.027, 0.024, 0.029, 0.032, 0.030, 0.029, 0.028, 0.022, 0.026, 0.023, 0.029, 0.029, 0.024, 0.032, 0.023, 0.030, and 0.031 miu/ml versus the expected result of 0.076 miu/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action.No results were reported and there is no reported allegation of patient harm as a result of this event this report is number three of four 3500a forms filed for this event, as four devices were affected.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• 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: 7326235
• MDR Text Key: 102279554
• Report Number: 3007111389-2018-00034
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/08/2018

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: 05/24/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5480
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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