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

Catalog Number 1912997

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros tsh results were obtained from multiple patient samples collected from the same patient, when tested on a vitros 5600 integrated system.The most likely assignable cause for the higher than expected vitros tsh results for patient 1 is the presence of a heterophilic sample interferent present in the patient samples tested.Based on historical quality control results, a vitros tsh lot 5550 performance issue is not a likely contributor to the event.There is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the events.

Event Description

The customer observed higher than expected vitros tsh results for a single patient sample using two different vitros tsh reagent lots processed on a vitros 5600 integrated system, when compared to the results obtained using a non-vitros method.Patient 1 results of 15.5, 12.8, 13.8 and 11.1miu/l (hypothyroid) vs.The expected results of 0.04 and 0.05 miu/l (hyperhyroid).Biased results of the direction and magnitude observed could lead to inappropriate physician action.The higher than expected vitros tsh results of 15.5, 12.8 and 13.8 miu/l were reported from the laboratory.From the information provided by the customer, it is assumed the patient was diagnosed with hypothyroidism during pregnancy and prescribed 112 mcg of levothyroxine.Once it was recognized the vitros tsh results were falsely elevated, the physician change the patients treatment, but the details of this change were not provided when requested.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one of two 3500a forms filed for this event, as two devices were affected.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

Event Description

Ortho clinical diagnostics (ortho) technical solutions center (tsc) followed up with the customer to determine the current status of the patient.The customer reported observing an additional higher than expected vitros tsh result from an alternate sample collected from a patient previously tested during a pregnancy.The additional sample was collected after delivery, as the customer was assessing if the cause of the initial higher than expected results were induced by the pregnancy.The vitros result was higher than expected when compared to the results obtained using a non-vitros method.Patient sample result of 14.7 miu/l (hypothyroid) vs.The expected result of 0.28 miu/l (hyperhyroid).Biased results of the direction and magnitude observed could lead to inappropriate physician action.It is unknown if the higher than expected vitros tsh result was reported from the laboratory as the customer did not provide this information, when requested.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4)/ qerts reference id (b)(4).

Manufacturer Narrative

This supplemental report is being filed to add an additional higher than expected, discordant, vitros tsh result obtained from an alternate sample collected from the same patient, the cause of which is the presence of a heterophilic sample interferent present in the patient sample which had been confirmed when a prior sample for the patient had been tested for heterophilic interference using heterophilic blocking tubes (hbt).

• 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
• MDR Report Key: 7224329
• MDR Text Key: 99000440
• Report Number: 3007111389-2018-00009
• 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
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5550
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention