MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 1387000

Device Problem Low Test Results (2458)

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

Event Date 09/23/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ft4 results were obtained from three patient samples, using vitros immunodiagnostics products ft4 reagent lots 3860 and 3910 processed on two vitros 5600 integrated systems (s/ns 56001974 and 56001973).A definitive assignable cause could not be determined.Based on historical quality control results for reagent lots 3860 and 3910, a vitros ft4 performance issue is not a likely contributor to the event.Since two different vitros 5600 integrated systems were affected, it is unlikely that an instrument related issue contributed to the event.The most likely assignable cause is a sample integrity or sample storage issue.The samples were left at room temperature for approximately 16 hours before being stored refrigerated at 2¿8 c.The vitros ft4 instructions for use (ifu) states that serum samples may be stored for up to 7 days at 2¿8 c (36¿46 f) or 4 weeks at -20 c (-4 f).However, the ifu also states that samples should be returned to 2¿8 c (36¿46 f) storage as soon as possible after use.The customer did not store the samples as described in the ifu.

Event Description

The customer obtained lower than expected vitros ft4 results for 3 patient samples tested using vitros immunodiagnostics products ft4 reagent on a vitros 5600 integrated system.(b)(6).Biased results of the direction and magnitude observed could lead to inappropriate physician action.The results obtained for patient samples 1 and 2 were reported outside of the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.(b)(4).This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 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: 6976483
• MDR Text Key: 91121915
• Report Number: 3007111389-2017-00168
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1387000
• Device Lot Number: 3910
• Other Device ID Number: 10758750008971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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