MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 81600N

Device Problem Calibration Problem (2890)

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

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex or weight.Beckman coulter (bec) customer technical support (cts) contacted the customer's onsite bio med service engineer.The engineer stated after replacement of the main pipettor/transducer the engineer ran water as negative samples and all access accutni+3 results were recovering as expected.The cause of the reported event is due to a malfunction of the main pipettor/transducer.

Event Description

The customer stated they noted indeterminate (ind) flagged troponin i (access accutni+3) results for four (4) patients on the laboratory's access 2 immunoassay system ( serial number (b)(4)).The customer repeat tested one (1) sample two (2) times on the same access 2 immunoassay system and obtained two (2) additional ind-flagged access accutni+3 results the purpose of the ind result flag is to alert the customer that a sample reading is outside the range of the current assay calibration curve and cannot be distinguished from a system or operator error and indicates that a final result cannot be calculated.It is provided to prevent reporting of potentially erroneous results, which it did in this case as intended.There was no report of any change or impact to patient care or treatment.Level one (1) quality control (qc) was recovering outside the customer's established limits.A precision run using low level qc material failed to meet performance specifications.Sample information, such as collection tube type, centrifugation time and speed, were not provided.The customer did not note any issues with sample integrity.

• Brand Name: ACCESS 2 IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: 5047421
• MDR Text Key: 24897257
• Report Number: 2122870-2015-00536
• Device Sequence Number: 0
• Product Code: MMI
• Reporter Country Code: US
• PMA/PMN Number: K922823/A007
• 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: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2007
• 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