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

Model Number	33000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The access vitamin b12 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.System performance indicators such as system checks and calibrations were not provided for review.Although the customer's level 1 and level 3 quality control were noted to shift low with the specific lot of reagent used, there is insufficient information to reasonably suggest a malfunction occurred.Customer's level 2 quality control was passing within specifications.(b)(4).In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
The customer reported erroneous low vitamin b12 (access vitamin b12, part number (b)(4) and lot number 921766) results were generated on the customer's dxi 800 access immunoassay analyzers (dxi) (part number (b)(4) and serial numbers (b)(4) and (b)(4).The customer reported additional erroneous low vitamin b12 results were also generated on the customer's dxi 800 access immunoassay analyzers at an alternate site (dxi part numbers and serial numbers not provided).The initial results were released from the laboratory.There was a report of change to patient treatment or management in association with this event.On (b)(6) 2020 the customer reported an unknown number of patients received vitamin b12 injections (doses not provided).There was no further information regarding change to patient treatment or management or patient outcome provided.System performance indicators such as system checks and calibrations were not provided for review.There was no report of hardware errors or other issues with the dxi instruments.No other assay issues were reported in conjunction with this event.Quality control information provided demonstrated a shift lower in the customer' quality control levels 1 and 3.Level 2 quality control remained stable.Customer did not report sample integrity issues.Sample collection information such as sample type and volume drawn, centrifugation time and speed, sample handling or processing were not provided.

• Brand Name: ACCESS VITAMIN B12 REAGENT
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10683918
• Report Number: 2122870-2020-00088
• Device Sequence Number: 2961752
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)210228(11)200229(10)921766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 921766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other