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

Catalog Number 1912997

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros tsh results were obtained from a vitros total thyroid (ttc) level 1 control fluid lot 678, when compared to the vitros pi mean, using a vitros tsh reagent on a vitros 3600 immunodiagnostic system.The assignable cause of the lower than expected vitros tsh results using the vitros ttc qc fluid lot 678 could not be determined.Based on historical quality control results, a vitros tsh lot 5375 performance issue is not a likely contributor to the event.Additionally, there was no evidence to suggest a vitros 3600 immunodiagnostic system malfunction and unexpected instrument performance is not a likely contributor to the event.

Event Description

A customer obtained lower than expected tsh results when testing vitros total thyroid level 1 control in combination with a vitros 3600 immunodiagnostic system.The following results breached vitros tsh potential health and safety criteria: vitros total thyroid control level1 lot 0678 tsh results 0.045, 0.051, 0.041,and 0.040 miu/l versus expected tsh result 0.097 miu/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros tsh qc fluid results were from non-patient fluids and so were not reported from the laboratory.However, the investigation could not conclude patient samples were not affected or would not be affected if the event were to recur undetected.There is no allegation of patient harm as a result of the event.This report is number two of three mdr's for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: 6598580
• MDR Text Key: 76483765
• Report Number: 3007111389-2017-00068
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/30/2017

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: 10/03/2017
• Device Catalogue Number: 1912997
• Device Lot Number: 5375
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• 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