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

Catalog Number 1912997

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected tsh result was obtained from a single patient sample using vitros tsh reagent lot 6390 on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tsh lot 6390 performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tsh reagent lot 6390.Vitros tsh diagnostic precision testing results processed on the vitros 5600 system were within ortho acceptable guidelines suggesting an instrument issue was not likely a contributing factor of the event.The precision testing was not performed around the time of the event, however, historical qc results around the time of the event were precise indicating that an instrument related issue was not a likely contributor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.A sample interferent was not able to be confirmed nor ruled out as a contributing factor of the event as no information was provided in regards to whether the patient was taking any medications or vitamin supplements around the time of the event.In addition, testing of the sample using heterophilic antibody blocking tubes was unable to be completed as no sample remains for further testing.Email address for contact office above is (b)(4).

Event Description

The customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a lower than expected thyroid stimulating hormone (tsh) result obtained from a single patient sample using vitros tsh reagent on a vitros 5600 integrated system.Vitros tsh = <0.015 versus expected 0.390 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected tsh result was reported from the laboratory; however, the physician questioned the result and repeat testing was performed using a new patient sample.There were no allegations of patient harm as a result of the 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11602421
• MDR Text Key: 249033491
• Report Number: 3007111389-2021-00043
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6390
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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