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 09/01/2014

Event Type  malfunction  

Event Description

The customer obtained lower than expected vitros tsh results on three samples from a single patient and on a quality control fluid tested on a vitros 5600 integrated system.Patient 1 vitros tsh results 0.15, 0.07, and 0.10 miu/l (hyperthyroid <0.465 miu/l ) verses expected non-vitros results 4.0, 2.23 miu/l (euthyroid 0.40 to 4.50 miu/l).Quality control result 3.265 miu/l verses expected result 5.54 miu/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The patient sample results were reported to a clinician.However, no treatment was altered, initiated, or stopped due to the reported tsh results.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 numbers (b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results were obtained on three samples from a single patient and on a quality control fluid tested on a vitros 5600 integrated system.A definitive root cause could not be determined.There is no indication that an instrument issue contributed to the event.An unexpected reagent performance issue could not be ruled out.Additionally, an unknown sample interferent present in the patient sample cannot be ruled out as contributing factor to the patient sample test results.

• 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: 4197562
• MDR Text Key: 20325771
• Report Number: 3007111389-2014-00225
• 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: 10/23/2014

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: 05/06/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2014
• 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