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

Catalog Number 1912997

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros tsh result was obtained from a patient sample processed using vitros immunodiagnostic products tsh reagent in combination with a vitros 5600 integrated system.A definitive assignable cause for the event could not be determined.Based on historical quality control results, a vitros tsh reagent lot 5755 performance issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros immunodiagnostic products tsh reagent lot 5755.Precision testing performed on the instrument yielded results that were within guidelines.Therefore, an instrument malfunction or unexpected performance is not a likely contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established the customer was not following the sample collection device manufacturer¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Moreover, sample handling and storage along with sample mix up cannot be completely ruled out as possible contributing factors to the event as the exact testing date and time was unable to be confirmed.

Event Description

A customer reported a lower than expected vitros tsh patient sample result obtained using vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system.Patient sample 2 result of 0.05 miu/l (hyperthyroid) vs.The expected result of 0.1 miu/l (hyperthyroid).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros tsh result was generated as part of a patient sample correlation study between two different vitros tsh reagent lots.The lower than expected vitros tsh result was not reported from the laboratory and there have been no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• 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: 8152302
• MDR Text Key: 131338750
• Report Number: 3007111389-2018-00190
• 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: 12/11/2018

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: 07/22/2019
• Device Catalogue Number: 1912997
• Device Lot Number: 5755
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1