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 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

Due to the unknown source of this complaint it is not possible to gather any further information other than the information provided in medwatch report mw5044913.It is unknown what vitros tsh reagent lot was in use at the time of the event as well as the tsh reference range for the two non-vitros methods that were being used to correlate with vitros tsh.In addition an unknown sample interferent that affects the vitros tsh assay but not the non-vitros methods or method to method differences cannot be ruled out.

Event Description

Ortho clinical diagnostic (ortho) department of safety risk management and surveillance (srms) received notification from the division of postmarket surveillance director of the us food and drug administration (fda) that a unidentified customer observed a lower than expected vitros tsh result from a single patient sample on a vitros 5600 integrated system when compared to a tsh result obtained on two non vitros methods.(medwatch report mw5044913).Vitros tsh result = 0.04 miu/l vs.Non vitros tsh results = 1.24 and 1.89 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.Ortho was not made aware of any allegation of patient harm due to this reported event.(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: 5220853
• MDR Text Key: 31248791
• Report Number: 3007111389-2015-00364
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

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 Catalogue Number: 1912997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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