MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE, PRODUCT CODE: JHI

Catalog Number 33500

Device Problem High Test Results (2457)

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

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth or weight.The access total bhcg reagent was not returned for evaluation.The elevated access total bhcg results as reported by the customer were confirmed to be generated from one specific reagent pack.The specific reagent pack has malfunctioned as non-reproducible elevated access bhcg results were obtained when utilizing this pack.The assignable cause of the malfunction could not be determined with the information provided.All associated mdrs for this event: mdr 2122870-2015-00664, mdr 2122870-2015-00665.

Event Description

The customer reported obtaining erroneously high human chorionic gonadotropin (access total bhcg) results on the access 2 immunoassay system (serial number (b)(4)).The customer identified a specific access total bhcg reagent pack (serial number (b)(4)) as contributing to the erroneous elevated results.On (b)(6) 2015, the customer analyzed two male samples utilizing the suspected access total bhcg reagent pack on the same access 2 immunoassay system to evaluate the specific reagent pack and obtained higher than expected results.Two male specimens were analyzed on the same access 2 immunoassay system, utilizing another access total bhcg reagent pack (serial number (b)(4)) of the same lot number and results within the normal reference range were obtained.On (b)(6) 2015, the customer ran a (b)(6) female sample utilizing the same suspected access total bhcg reagent pack (serial number (b)(4)) on the same access 2 immunoassay system and obtained a non-reproducible elevated result.The same female sample was then repeated using another access total bhcg reagent pack (serial number (b)(4)) on the same access 2 immunoassay system and lower results were obtained.Mdr 2122870-2015-00665 will address the access total bhcg result obtained on (b)(6) 2015.The initial results were released from the laboratory.There was no report of patient injury or change in patient treatment associated with this event.Access total bhcg calibration was passing assay specifications.Quality control (qc) data were not provided.System checks have been passing instrument specifications.The customer did not provide sample handling information such as collection device and centrifugation conditions.No sample integrity issues were reported.

• Brand Name: ACCESS TOTAL BHCG
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE, PRODUCT CODE: JHI
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5153024
• MDR Text Key: 28378872
• Report Number: 2122870-2015-00664
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/21/2015

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: 03/31/2016
• Device Catalogue Number: 33500
• Device Lot Number: 438910
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1