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 Code Available (3191)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

The customer did not provide patient weight.A beckman coulter (bec) field service engineer (fse) was dispatched to assess instrument performance.The fse proactively performed preventative maintenance on the access 2 immunoassay system.The fse did not note any system malfunction that would have contributed to the reported event.The access ck-mb reagent pack was not returned for evaluation.In conclusion, the cause of the non-reproducible access accutni+3 and access ck-mb results cannot be determined with the available information.(b)(4).All mdrs associated with this report: mdr2122870-2015-00618; mdr2122870-2015-00619.

Event Description

The customer reported non-reproducible troponin i (access accutni+3) and creatine kinase-muscle brain isoform (access ck-mb) results for one (1) patient on the access 2 immunoassay system (serial number (b)(4)).The customer runs all access accutni+3 samples in duplicate.It was noted both of the initial access accutni+3 results were elevated, above the normal reference range of the assay.The customer repeat tested the samples on the same access 2 immunoassay system and obtained lower results, within the normal reference range of the assays.Mdr2122870-2015-00618 addresses the access accutni+3 results.Mdr2122870-2015-00619 addresses the access ck-mb results.The initial elevated results were reported outside the laboratory and the patient was admitted to the hospital.All system parameters including access accutni+3 and access ck-mb quality control (qc), access accutni+3 and access ck-mb calibrations and system check were within assay specifications and instrument specifications.Sample information such as collection device, centrifugation speed and time were not provided.No issues with sample integrity were reported by the customer.

• 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
• MDR Report Key: 5105312
• MDR Text Key: 26824012
• Report Number: 2122870-2015-00619
• 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: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 386371
• Device Lot Number: 437908
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR