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

Catalog Number 1912997

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results from five out of five different proficiency sample fluids processed on a vitros 5600 integrated system.The assignable cause of the event is unknown; however, inappropriate pre-analytical sample handling or an issue with the proficiency fluids cannot be ruled out as contributing factors.Based on the review of historical quality control performance, there is no evidence that a reagent issue contributed to the event.There was no indication that instrument malfunctions occurred, however, an instrument issue cannot be entirely ruled out as the customer declined precision testing to confirm vitros 5600 instrument performance.

Event Description

A customer observed lower than expected vitros tsh results from four out of 5 different proficiency sample fluids processed on a vitros 5600 integrated system.Sample 1 result = 3.12 miu/l vs.Expected = 5.89 miu/l.Sample 2 result = 0.25 miu/l vs.Expected = 0.563 miu/l.Sample 3 result = 10.8 miu/l vs.Expected = 21.98 miu/l.Sample 4 result= 4.27 miu/l vs.Expected = 5.85 miu/l.Sample 5 result= 9.86 miu/l vs.Expected = 20.58 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm made as a result of the event.This report corresponds to ortho clinical diagnostics inc.(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: 5148442
• MDR Text Key: 28643415
• Report Number: 3007111389-2015-00332
• 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: Medical Technologist
• Report Date: 10/13/2015

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: 04/18/2016
• Device Catalogue Number: 1912997
• Device Lot Number: 4740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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