MAUDE Adverse Event Report: BECKMAN COULTER ACCESS CK-MB REAGENT; FLUOROMETRIC METHOD, CPK OR ISOENZYMES

Catalog Number 386371

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics, such as age or weight.The customer provided the patient was born in 1989.The customer performed hardware verification to include obtaining a passing access ck-mb precision run and system check.A beckman coulter (bec) field service engineer (fse) verified operation of the instrument by performing a passing access ck-mb precision run.The fse did not note any hardware malfunctions.The access ck-mb reagent was not returned for evaluation.The cause of the non-reproducible accessck-mb results cannot be determined with the available information.

Event Description

The customer noted non-reproducible creatine kinase-muscle brain isoform (access ck-mb) patient results for one (1) female patient.The customer repeat tested the sample several times on the same unicel dxi 600 access immunoassay system and obtained erratic results.The customer repeat tested the sample on an alternate unicel dxi 600 access immunoassay system (serial number (b)(4)) and obtained lower results, within the normal reference range of the assay.The customer obtained a second sample from the patient and tested the sample on the alternate unicel dxi 600 access immunoassay system (serial number (b)(4)) and obtained lower results, within the normal reference range of the assay.There was no report of patient injury or change in patient treatment associated with this event.All system parameters (including quality control (qc), access ck-mb calibration, access ck-mb precision run and system check) were within assay and instrument specifications.Samples are collected in lithium heparin gel separator tubes.Samples are centrifuged at 2600 relative centrifugal force (rcf) for ten (10) minutes at room temperature the customer did not note any issues with sample integrity.

• Brand Name: ACCESS CK-MB REAGENT
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jeffery koll ; 1000lake hazektine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5091837
• MDR Text Key: 26479785
• Report Number: 2122870-2015-00594
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/29/2015

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: 04/30/2016
• Device Catalogue Number: 386371
• Device Lot Number: 527148
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• 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