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 Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

The customer observed lower than expected vitros tsh results from a single patient sample on a vitros eci immunodiagnostic system when compared to tsh results obtained on a non vitros method.A definitive root cause could not be identified, however, an unknown sample interferent that affects the vitros assay but not the non vitros assay cannot be ruled out as contributing to the event.Although there is no evidence that suggests a vitros tsh reagent or an instrument issue occurred, neither can be completely ruled out as contributing factors to the event.The issue is isolated to one sample from one specific patient.

Event Description

The customer observed lower than expected vitros tsh results from a single patient sample on a vitros eci immunodiagnostic system when compared to tsh results obtained on a non vitros method.Vitros tsh results = 5.56 and 4.56 miu/l vs.Non vitros tsh result = 12.07 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected tsh results were not reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report is number one of two mdr's for this event.Two 3500a forms are being submitted for this event as two 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: 5153610
• MDR Text Key: 28729442
• Report Number: 3007111389-2015-00338
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Report Date: 10/15/2015

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: 01/14/2016
• Device Catalogue Number: 1912997
• Device Lot Number: 4780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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