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

Catalog Number 1912997

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected thyroid stimulating hormone (tsh) results were obtained from a single patient sample using vitros immunodiagnostic products tsh reagent lot 6415 on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Historical quality control results from the customers biorad qc for vitros tsh lot 6415 indicate imprecision at levels 2 and 3.However, the vitros tsh qc was within expectation on the day of the event, indicating acceptable vitros tsh lot 6415 reagent performance at that time.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tsh reagent lot 6415.A vitros tsh diagnostic precision test was not performed on the on the vitros 5600 system either at the time of the event or currently.A review of the vitros tsh qc using the customers current lot of vitros tsh (lot 6425) shows acceptable performance; however, the vitros tropi es diagnostic precision test indicated that there is a possible instrument issue and service actions were suggested to resolve.Therefore, an instrument issue cannot be fully ruled out as a contributor to 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 not performed.Email address for contact office (b)(4).

Event Description

The investigation determined that higher than expected thyroid stimulating hormone (tsh) results were obtained from a single patient sample using vitros immunodiagnostic products tsh reagent lot 6415 on a vitros 5600 integrated system.The results were higher than expected when compared to the result from a redraw sample from the patient obtained using an unknown chemiluminescent method.Patient sample vitros tsh results of 7.47 and 7.20 miu/l vs the expected result of 2.89 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros tsh result was reported from the laboratory.However, a physician questioned the result and no treatment was initiated, altered or stopped based on the reported result.There is no allegation of patient harm as a result of this event.This report is number two of two 3500a forms filed for this event, as two devices were affected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• 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: 11957361
• MDR Text Key: 266239905
• Report Number: 3007111389-2021-00083
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/08/2021

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: 11/17/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6415
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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