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

Catalog Number 1912997

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Palpitations (2467); No Code Available (3191)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined a lower than expected vitros tsh result was obtained when processing a patient sample on a vitros 5600 system when compared to a non-vitros beckman tsh result.Additionally lower than expected fsh, lh, prol and higher than expected cort and testosterone (testo) results were also obtained from the same patient.The most likely assignable cause of the event is biotin interference.The patient was taking a daily biotin supplement of 5.0 mg/day.Vitros tsh, fsh, lh, prol, cort, or testo assays are susceptible to biotin interference.Non-vitros tsh, prol, cort, and testo results obtained from methods not affected by biotin interference generated expected results from the patient samples.In addition, vitros fsh, lh, prol and testo results were closer to the expected results 2 days after the patient discontinued taking the biotin supplements, when the biotin was starting to clear from the patient's system.Ortho previously issued a 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, fsh, lh, prol, cort, or testo assays.These vitros assays include the use of streptavidin-biotin in the design which may be susceptible to biotin interference.Therefore, the biotin in the samples is a potential interfering substance and cannot be ruled out as contributing to the event.

Event Description

An article published in journal of the endocrine society (jes), a peer-reviewed medical journal published monthly by the endocrine society.(suspected testosterone-producing tumor in a patient taking biotin supplements (jes.2018) doi/10.1210/js.2018-00069/4994589) documented a case study involving a (b)(6)-year-old caucasian woman presented to the endocrinology clinic with palpitations, inability to lose weight and hirsutism.The referring provider questioned whether these symptoms might be related to the patient¿s known thyroid dysfunction, subclinical hyperthyroidism, previously diagnosed.The patient was taking a daily biotin supplement of 5.0 mg/day.A lower than expected vitros tsh result was obtained from a patient sample tested on a vitros 5600 system when compared to a non-vitros beckman tsh result which is not susceptible to biotin interference.Patient sample vitros tsh results of 0.06 miu/l vs.The expected tsh result of 1.1 miu/l biased tsh results of the direction and magnitude observed could lead to inappropriate physician action.Additionally, based on lower than expected vitros prolactin (prol) and higher than expected vitros cortisol (cort) results, the patient underwent a ct scan and mri.Based on medical consultations with the ortho medical safety officer, serious long term health impact from the mri or ct procedures is not anticipated.Ortho was not made aware of any allegation of actual patient harm due to the event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7594314
• MDR Text Key: 112042353
• Report Number: 3007111389-2018-00083
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1912997
• Device Lot Number: NOT PROVIDED
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other