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

Catalog Number 1912997

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined lower than expected tsh results were obtained from a patient sample processed using vitros tsh reagent on a vitros xt7600 integrated system.Investigation was not able to determine an assignable cause for this event.A vitros tsh lot 6420 reagent issue is an unlikely contributor to the event, as vitros ttc and biorad qc results leading up to the event were within acceptable guidelines.Additionally, 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 6420.There was no evidence to suggest an instrument malfunction on either recently installed vitros xt7600 integrated system.However, precision testing was not conducted on the instruments when requested, therefore, an instrument issue cannot be entirely ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not established whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample.Additionally, since the quality control results for j1 and j2 were concordant on the day of the event, a patient sample mix up is a possible cause of the discordant results for patient 1 between the two systems, although this could not be confirmed.Email address for contact office is (b)(4).

Event Description

The investigation determined that discordant, lower than expected vitros tsh results were obtained from three patients when tested using vitros tsh lot 6420 on two vitros xt7600 integrated systems.The results were discordant when compared to a tosoh tsh result for the patient.Patient 1, vitros tsh results of 0.398 miu/l (hyperthyroid) and 0.523 miu/l (euthyroid) versus the tosoh result of 12.5 miu/l (hypothyroid).Biased results of the direction and magnitude observed could lead to inappropriate physician action.The lower than expected vitros tsh results for the patients were not reported from the laboratory to a physician and were not used to aid in diagnosis but were generated during validation or method comparison testing.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number/qerts reference id (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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11581329
• MDR Text Key: 262878928
• Report Number: 3007111389-2021-00041
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: 6240
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• 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