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 05/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros thyroid stimulating hormone (tsh) results were obtained when processing samples from four different patients using vitros immunodiagnostics products tsh reagent lot 6060 in combination with a vitros 5600 integrated system.The results were lower than expected when compared to results from a non-vitros roche system.A definitive assignable cause could not be determined for the lower than expected patient sample results.Based on historical quality control results, a vitros tsh lot 6060 performance issue is not a likely contributor to the events and there was no indication the vitros tsh reagent in use or the vitros 5600 integrated system malfunctioned in any way.However, an instrument issue cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer at the time of the event.In addition, it was not possible to establish if the customer was following the sample collection device manufacturer¿s recommendation for sample centrifugation.Therefore, 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 samples, although this could not be confirmed.A possible cause for the lower than expected vitros tsh patient sample results is an unknown sample specific interferent present in the patient samples themselves.However, the customer failed to provide when requested, any additional testing results using appropriate blocking tubes.Therefore, the presence of an unknown sample interferent causing the lower than expected vitros tsh results cannot be completely ruled out.Additionally, it was established that patient 4 was in receipt of a list of medications for a skin condition and the medications or their metabolites cannot be ruled out as a potential cause of the lower than expected result for that patient.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6060.

Event Description

A customer reported lower than expected vitros thyroid stimulating hormone (tsh) results obtained when processing samples from four different patients using vitros immunodiagnostics products tsh reagent in combination with a vitros 5600 integrated system.The results were lower than expected when compared to results from a non-vitros roche system at an alternate site.Patient 1 results of 0.412 and 0.432 miu/l (hyperthyroid) versus the expected result of 0.72 miu/l (euthyroid).Patient 2 results of 0.431 and 0.390 miu/l (hyperthyroid) versus the expected result of 0.65 miu/l (euthyroid).Patient 3 results of 0.213 and 0.208 miu/l (hyperthyroid) versus the expected result of 0.40 miu/l (euthyroid).Patient 4 result of 0.416 miu/l (hyperthyroid) versus the expected result of 2.14 miu/l (euthyroid).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.It is not known if the lower than expected vitros tsh results were reported from the laboratory.However, there has been no allegation of patient harm as a result of the event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.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: 10159524
• MDR Text Key: 220695118
• Report Number: 3007111389-2020-00062
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: AE
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 6060
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• 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