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

Catalog Number 1912997

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 09/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, lower than expected vitros tsh results were obtained from un-treated patient samples processed using a vitros tsh reagent in combination with a vitros 5600 integrated system.The results were discordant when compared to vitros tsh results from the same patient samples pre-treated with streptavidin microparticles and when using a non-vitros (beckman) system for the un-treated patient samples.The most likely cause of the discordance between the vitros tsh results when untreated samples and pre-treated samples were compared and when the untreated vitros tsh results and the untreated non-vitros (beckman) results are compared is likely due to the presence of biotin in the untreated samples.In july 2018, ortho issued a customer communication (cl2018-149) 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).The 21 patient samples used in the study were specifically selected as the patients were suspected of consuming biotin, therefore, the samples were suitable for the purpose of the study which was the characterization of biotin interference in vitros immunoassays.Ortho was not made aware of any allegation of actual patient harm as a result of the lower than expected tsh results.

Event Description

A customer obtained discordant, lower than expected vitros tsh results from un-treated patient samples processed using a vitros tsh reagent in combination with a vitros 5600 integrated system.The results were discordant when compared to vitros tsh results from the same patient samples pre-treated with streptavidin microparticles and when using a non-vitros (beckman) system for the un-treated patient samples.Patient 1 untreated serum vitros tsh result of 1.860 miu/l versus the pre-treated vitros tsh result of 5.2 miu/l.Patient 2 untreated serum vitros tsh result of 0.350 miu/l versus the pre-treated vitros tsh result of 0.53 miu/l.Patient 10 untreated serum vitros tsh result of 0.420 miu/l versus the pre-treated vitros tsh result of 6.420 miu/l.Patient 11 untreated serum vitros tsh result of 0.730 miu/l versus the pre-treated vitros tsh result of 7.250 miu/l.Patient 12 untreated serum vitros tsh result of 0.260 miu/l versus the pre-treated vitros tsh result of 1.370 miu/l.Patient 13 untreated serum vitros tsh result of 1.350 miu/l versus the pre-treated vitros tsh result of 2.370 miu/l.Patient 14 untreated serum vitros tsh result of 0.050 miu/l versus the pre-treated vitros tsh result of 0.730 miu/l.Patient 15 untreated serum vitros tsh result of 2.200 miu/l versus the pre-treated vitros tsh result of 13.750 miu/l.Patient 16 untreated serum vitros tsh result of 0.260 miu/l versus the pre-treated vitros tsh result of 2.350 miu/l.Patient 1 untreated serum vitros tsh result of 1.860 miu/l versus the untreated serum beckman tsh result of 4.6 miu/l (dxi).Patient 9 untreated serum vitros tsh result of 16.060 miu/l versus the untreated serum beckman tsh result of 24.4 miu/l (dxi).Patient 10 untreated serum vitros tsh result of 0.420 miu/l versus the untreated serum beckman tsh result of 7.1 miu/l (dxi).Patient 11 untreated serum vitros tsh result of 0.730 miu/l versus the untreated serum beckman tsh result of 5.88 miu/l (dxc).Patient 14 untreated serum vitros tsh result of 0.050 miu/l versus the untreated serum beckman tsh result of 0.8 miu/l (dxi).Patient 15 untreated serum vitros tsh result of 2.200 miu/l versus the untreated serum beckman tsh result of 10.72 miu/l (dxc).Biased results of the direction and magnitude observed may lead to inappropriate physician action.The discordant, lower than expected vitros tsh results were obtained during a clinical study for the clinical biochemistry journal and were not reported to physicians.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• 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: 9395619
• MDR Text Key: 220565806
• Report Number: 3007111389-2019-00190
• 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: 12/02/2019

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?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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