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

Catalog Number 1912997

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 an ortho employee became aware of a published article "erroneous thyroid diagnosis due to over the counter biotin" [nutrition (www.Nutritionjrnl.Com(nutrition 57(2019)257)].The article documented 4 patient case studies to demonstrate the effect of high biotin doses available to consumers have on biotin-streptavidin immunoassay results when using vitros tsh reagent on a vitros 5600 integrated system.The most likely assignable cause of the lower than expected vitros tsh results is the presence of biotin in the samples.Each of the 4 patients were discovered to be taking biotin supplements.In july 2018, ortho issued a customer communication to alert customers that biased results may occur for specific vitros immunodiagnostic products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).For the vitros tsh assay, a negative bias may be observed (= 10% bias) in samples with a biotin concentration of 5 ng/ml (0.5 ¿g/dl).Since all four patients were taking biotin, the likely cause of the lower than expected tsh results is the use of biotin.There was no evidence presented in the article that vitros tsh reagent or the vitros 5600 system was not performing as expected.The initial lower than expected vitros tsh results were reported outside of the laboratory for each of the 4 patients; however ortho was not made aware of any allegation of patient harm as a result of the events.

Event Description

On (b)(6) 2019 an ortho employee became aware of a published article "erroneous thyroid diagnosis due to over the counter biotin" [nutrition (www.Nutritionjrnl.Com(nutrition 57(2019)257)].The article documented 4 patient case studies to demonstrate the effect of high biotin doses available to consumers have on biotin-streptavidin immunoassay results when using vitros tsh reagent on a vitros 5600 integrated system.Patient 1, vitros tsh result 0.2 miu/l versus expected vitros tsh result 2.8 miu/l.Patient 2, vitros tsh result 0.142 miu/l versus expected vitros tsh result 0.937 miu/l.Patient 3, vitros tsh result 0.24 miu/l versus expected vitros tsh result 5.5 miu/l.Patient 4, vitros tsh result 0.193 miu/l versus expected normal vitros tsh result (result not provided).Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The initial lower than expected vitros tsh results were reported outside of the laboratory for each of the 4 patients; however ortho was not made aware of any allegation of actual patient harm as a result of the events.This report corresponds to ortho clinical diagnostics inc (ortho).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: 8359742
• MDR Text Key: 139830385
• Report Number: 3007111389-2019-00034
• 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: 02/21/2019

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 Catalogue Number: 1912997
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/21/2019
• 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