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 Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

A customer complained after observing lower than expected vitros tsh results for a single patient sample, processed on a vitros 5600 system, which produced numerically higher non-vitros tsh results for the same sample.Vitros tsh results of 0.026 and 0.042 miu/l vs.Expected 0.9 and 0.93 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action.The vitros tsh results were reported to a physician and questioned.There were no allegations of patient harm made as a result of the events.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.(b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results for a single patient sample, processed on a vitros 5600 system, produced numerically higher non-vitros tsh results for the same sample.Root cause for the lower than expected vitros tsh results could not be determined with the information available to date, however, the possibility that unexpected vitros tsh reagent or vitros 5600 system performances had contributed to the results could not be ruled out entirely.

• 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: 4341977
• MDR Text Key: 5205016
• Report Number: 3007111389-2014-00269
• 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: 12/18/2014

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: 07/14/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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