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

Catalog Number 6802220

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected vitros bhcg result was obtained when processing a patient sample on a vitros 5600 integrated system.The investigation was unable to determine the assignable cause for this event.There is no evidence to suggest a vitros 5600 system issue or a vitros bhcg ii reagent issue contributed to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer is not adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.It is likely 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 higher than expected vitros total bhcg (bhcg) result from a patient sample on a vitros 5600 integrated system.Patient sample, vitros bhcg result 13.34 miu/ml versus expected vitros bhcg result <2.39 miu/ml biased results of the direction and magnitude observed may lead to inappropriate medical action if not detected.The initial total bhcg ii result was reported to physicians, however, corrected reports were generated and there was no allegation of patient harm being made as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG 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: 7637430
• MDR Text Key: 112862341
• Report Number: 3007111389-2018-00092
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2019
• Device Catalogue Number: 6802220
• Device Lot Number: 2080
• Other Device ID Number: 10758750002320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• 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