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

Catalog Number 6802220

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, higher than expected vitros bhcg result was obtained from a single patient sample on a vitros eciq immunodiagnostic system.The definitive assignable cause could not be determined, however, based on condition codes indicating the lis and vitros system were not communicating, and multiple condition codes for sample mismatch and program issues, pre-analytical sample mix up cannot be ruled out as contributing to the event, although this could not be confirmed.Based on historical quality control results and vitros bhcg within-run precision testing, there was no indication the vitros bhcg reagent or the vitros eciq system malfunctioned.Additionally, it was unknown if the affected patient sample was centrifuged according to the sample device manufacturer¿s recommendations, therefore, improper pre-analytical sample processing cannot be ruled out as contributing to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.A definitive assignable cause for the event could not be determined.

Event Description

A customer obtained a non-reproducible, higher than expected, vitros bhcg result from a single patient sample when processed on a vitros eciq immunodiagnostic system.Patient sample result of 79.1 miu/ml versus < 2.39 miu/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The non-reproducible, higher than expected vitros bhcg results was not reported outside of the laboratory and there was no report of actual patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS BHCG II 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: 6375397
• MDR Text Key: 69280864
• Report Number: 3007111389-2017-00024
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2017
• Device Catalogue Number: 6802220
• Device Lot Number: 1738
• Other Device ID Number: 10758750002320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1