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 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected, vitros tsh result was obtained from a single patient sample when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tsh lot 5505 performance issue is not a likely contributor to the event.Additionally, there was no evidence to suggest a vitros 5600 integrated system malfunction; however, it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer obtained a non-reproducible higher than expected vitros tsh result when processing a single patient sample on a vitros 5600 integrated system.Patient sample 1 result of >100 miu/l vs.The expected result of 0.021 miu/l.A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The non-reproducible, higher than expected, vitros tsh result was not reported from the laboratory and ortho was not made aware of any allegation of patient harm as a result of this event.(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: 7301134
• MDR Text Key: 101572466
• Report Number: 3007111389-2018-00026
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/27/2018

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 Expiration Date: 07/03/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5505
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1