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

Catalog Number 1912997

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

The customer observed a non-reproducible, higher than expected vitros tsh result for a single patient sample processed on a vitros 5600 integrated system.Vitros tsh result of 16.366 miu/l vs.An expected result of <0.01 miu/l.The patient result was reported to a physician who questioned the result.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.No treatment was altered and there was no allegation of patient harm as a result of this event.(b)(4).

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected tsh result occurred on a single patient sample.A definitive root cause for the event could not be determined.Historical tsh quality control results were acceptable prior to the event, indicating the vitros tsh reagent was performing as intended.An unknown sample interferent or an unexpected vitros 5600 system performance issue cannot be ruled out as contributing to the event.

• 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: 4132899
• MDR Text Key: 15356107
• Report Number: 3007111389-2014-00215
• 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: 10/01/2014

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: 03/17/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• 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