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

Catalog Number 1912997

Device Problems High Readings (2459); Low Readings (2460)

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

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected tsh results were obtained from two different patient samples tested on a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause.No vitros tsh reagent performance issues are indicated based on the historical tsh quality control data.An instrument related event has been ruled out as a contributing factor as within-run precision testing was within the acceptable guidelines.There was no evidence that the vitros 5600 system or vitros tsh reagent had malfunctioned.Pre-analytical sample handling is unlikely to have contributed to this event, however the possibility of a sample mix up cannot be completely ruled out as contributing to the event, although it cannot be confirmed.In addition, for the patient 2 vitros result, it is possible that an interferent that affects the vitros tsh assay but not the roche assay may have contributed to this event, however this cannot be confirmed.The definitive assignable cause is unknown.

Event Description

The customer obtained one higher than expected (patient sample 1), and one lower than expected (patient sample 2) tsh results from two patient samples tested on a vitros 5600 integrated system.The higher than expected result obtained from patient sample 1 was compared to a tsh result obtained from an alternate sample and the lower than expected result obtained from patient sample 2 was compared to a tsh result obtained from the same sample tested on a non-vitros roche system.Patient sample 1 results 6.16 miu/ml versus expected result 3.55 miu/ml.Patient sample 2 result 0.347 miu/ml versus non-vitros expected result 0.6 miu/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The higher than expected vitros tsh result obtained from patient 1 was reported outside of the laboratory, however, no treatment was given, changed, or withheld based on the reported vitros tsh result.The lower than expected vitros tsh result obtained from patient 2 was not reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report is number two of two 3500a forms filed for this event, as two devices were affected.(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: 7004652
• MDR Text Key: 92605457
• Report Number: 3007111389-2017-00175
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5460
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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