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

Catalog Number 6802220

Device Problem High Readings (2459)

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

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected vitros bhcg results were obtained from a single patient sample when processed on two vitros 5600 integrated systems.The most likely assignable cause is pre-analytical sample handling leading to possible contamination and/or evaporation of the sample.However, a reagent issue or an instrument issue cannot be completely ruled out, they are not likely to be contributing factors to this event.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 higher than expected, vitros bhcg results from a single patient sample when processed on two vitros 5600 integrated systems.Patient sample results of 135.2, 136.2, 145.1, 157.9, 158.6, and 173.3 miu/ml versus expected result <2.39miu/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The higher than expected vitros bhcg results were not reported outside of the laboratory and there was no report of actual patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics (ortho).(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: 6438880
• MDR Text Key: 71324863
• Report Number: 3007111389-2017-00038
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2017
• Device Catalogue Number: 6802220
• Device Lot Number: 1658
• Other Device ID Number: 10758750002320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1