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

Catalog Number 1912997

Device Problems Low Readings (2460); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results were observed when processing multiple sample draws from three different patients on two vitros 5600 integrated systems.The likely assignable cause of the event is an interferent causing the lower than expected vitros tsh results.Patient 1 and patient 3 were taking biotin supplements at the time of the draw.Per the tsh instructions for use, ortho has not quantified the interfering effect of biotin on the tsh assay at biotin concentrations >0.5 ug/dl.However, on 14 february 2018 ortho issued customer letter ¿information on how biotin may affect specific vitros microwell assays¿ to alert customers of the effect high-dose biotin supplements have on some vitros immunodiagnostics products (microwell assays) such as the vitros tsh assay.The vitros tsh assay includes the use of streptavidin-biotin in the design which may be susceptible to biotin interference.Therefore, the lower than expected vitros tsh results obtained is likely caused by biotin interference.In the case of patient 2, since the tsh levels are consistently low (hyperthyroid) and the ft4 are consistently normal (euthyroid) for each draw, the presence of an unknown interferent from a medication (or combination of medications) is the likely cause of the lower than expected tsh results.There is no evidence that a vitros tsh reagent issue or a vitros 5600 system issue contributed to the lower than expected vitros tsh results.

Event Description

A customer observed consistently lower than expected vitros tsh results obtained from multiple sample draws from three different patients.The vitros tsh results were all considered hyperthyroid when corresponding vitros ft4 results obtained from the same samples were all considered euthyroid.The vitros tsh and ft4 results from each sample are summarized below.(b)(6).The true tsh value for each sample draw is unknown, however as the vitros tsh values are consistently below the reference interval (hyperthyroid) and the vitros ft4 results are consistently within the reference interval (euthyroid), ortho as conservatively decided to report this event.A lower than expected tsh result of the magnitude described above may lead to inappropriate medical action if not detected.It is unknown if the lower than expected, vitros tsh results were reported from the laboratory.However, ortho was not made aware of any allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: INVITRO 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7382922
• MDR Text Key: 104157175
• Report Number: 3007111389-2018-00046
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5590
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1