MAUDE Adverse Event Report: BECKMAN COULTER ACCESS VITAMIN B12 REAGENT; RADIOASSAY, B12

Model Number 33000

Device Problem High Test Results (2457)

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

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as weight, ethnicity or race.The access b12 reagent was not returned for evaluation.All assay and system verifications met specifications at the time of this incident.No hardware errors, flags or other assay issues were reported in conjunction with this event.The cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2019 the customer reported that non-reproducible elevated vitamin b12 (access vitamin b12) results had been generated on the customer's unicel dxi800 immunoassay system (serial number (b)(4)) for one patient sample.The initial elevated vitamin b12 result was 219.23 pmol/l was released from the laboratory.The sample was sent to another laboratory and repeated with an alternate method (not provided); result provided was <111 pmol/l.There was no report of change to patient care or treatment.Calibration, quality control and system check were all performing within specifications at the time of the incident.Information regarding patient sample collection and processing was not provided.

• Brand Name: ACCESS VITAMIN B12 REAGENT
• Type of Device: RADIOASSAY, B12
• 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: david davis ; 250 s. kraemar blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8331842
• MDR Text Key: 139066204
• Report Number: 2122870-2019-01046
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)190630(11)180630(10)831320
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K140496
• 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
• Type of Report: Initial
• Report Date: 02/12/2019

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: 06/30/2019
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 831320
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/30/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR