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

Model Number	33000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RADIOASSAY, B12
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8331842
• Report Number: 2122870-2019-01046
• Device Sequence Number: 16552816
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)190630(11)180630(10)831320
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K140496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 831320
• Distributor Facility Aware Date: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1
• Patient Age: 39 YR