MAUDE Adverse Event Report: BECKMAN COULTER ACCESS AFP REAGENT; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Catalog Number 33211

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/20/2014

Event Type  malfunction  

Event Description

The customer reported quality control (qc) imprecision, and non-reproducible results for alpha-fetoprotein (access afp), for one patient sample, generated on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)).There was no reported change in treatment or injury to the patient in connection with this event.The sample was frozen serum sent to the customer by a satellite lab in a sarstedt pour off tube.The tube was thawed and mixed, before being placed on the analyzer.No centrifugation was done.There was no reported sample integrity.The most recent system check passed with results within service specifications.Afp calibration also passed and a review of the qc data indicates that all three levels were within customer expected range before the event.

Manufacturer Narrative

The patient's actual date of birth and weight were not provided by the customer.There is no indication that access accutni+3 reagent was returned for evaluation.A beckman coulter field service engineer (fse) was dispatched to the site to evaluate the instrument.The fse ran a system check, which passed for all measured parameters.There was no indication of an instrument malfunction.The cause of the event is unknown and cannot be determined with the available information.To date, the customer has not reported any further issues.Bec internal identifier for this report is (b)(4).

Manufacturer Narrative

There is no indication that access afp reagent was returned for evaluation.

• Brand Name: ACCESS AFP REAGENT
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• 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: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 4348673
• MDR Text Key: 5222549
• Report Number: 2122870-2014-00836
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 33211
• Device Lot Number: 427180
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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 Age: 33 YR