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

Catalog Number 1912997

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros tsh result was obtained from a single patient sample processed on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Vitros tsh within-run precision testing was not performed, therefore a vitros 5600 system issue could not be ruled out as a contributor to the event.Historical quality control results were not provided, therefore a vitros tsh lot 4980 performance issue could not be ruled out as a contributor to the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer is processing the samples following the sample collection device manufacturer¿s recommendations.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The hemolysis index was flagged with ¿es¿ (examine sample), and the indices values for turbidity and icterus were higher than expected indicating that the integrity of the sample is in question and may be a contributing factor to the event.The definitive assignable cause is unknown.

Event Description

A customer obtained a higher than expected vitros tsh result on a single patient sample processed on a vitros 5600 integrated system.Patient: 20 miu/l vs.0.9 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The higher than expected vitros tsh patient result was reported from the laboratory and a single dose of medication (thyronorm) was administered to the patient due to the higher than expected tsh result.It is unknown what dosage of thyronorm was administered.The patient was not given any medication after the initial dose and was discharged from the hospital.Ortho clinical diagnostics (ortho) was not made aware of any allegation of actual patient harm as a result of this 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: 5705529
• MDR Text Key: 48101431
• Report Number: 3007111389-2016-00098
• 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
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2016
• Device Catalogue Number: 1912997
• Device Lot Number: 4980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• 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