MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS VITAMIN B12 COBALAMIN; RADIOASSAY, VITAMIN B12

Model Number 33000

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  Injury  

Event Description

The customer reported an increased number of low vitamin b12 (access vitamin b12, part number 33000 and lot number 272031) patient results were generated for month of may2022 on the customer's dxi 800 access immunoassay analyzers (part number a71456 and serial numbers (b)(4) and (b)(4)).There was a report of change to patient treatment or management in association with this event.The customer wasn¿t sure how many patients but reported that at least one patient received unnecessary b12 supplementation (doses not provided).There was no further information regarding change to patient treatment or management or patients outcome provided.There was no report of hardware errors or other issues with the dxi instruments.Both analyzers have had all maintenance completed and preventative maintenance is not overdue.No other assay issues were reported in conjunction with this event.Per customer verbal reports, weekly system checks passed.Calibrations passed and quality control (qc) were within ranges on both analyzers.The vitamin b12 reagent lot was not changed.Low level b12 eqa samples from april have been rerun and the results are fine and in keeping with the beckman group.The customer reported a jump in the percentage of vitamin b12 deficient results only for month of may.A batch of samples run on (b)(6) 2022 was rechecked.Samples are from a mix of general practitioner surgeries and outpatient clinics.All were analyzed same day as received (within 24 hours).Patient samples were run across both analyzers.The original results were lower than the repeated ones.Then a 10 replicates precision check was performed on dxi serial number (b)(4) with a pool of 2 samples and it passed.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.

Manufacturer Narrative

The full patient identifier is (b)(6).The number of patients involved is unknown.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 passing within specifications at the time of the event.The local support compared the customer¿s calibrations with other customer¿s ones, no difference was seen.The vitamin b12 reagent lot 272031 used by the customer did not demonstrate any shift at other laboratories.A batch of samples run on (b)(6) 2022 was rechecked.Patient samples were run across both analyzers.The original results were lower than the repeated ones and a 10 replicates precision check was performed on dxi serial number (b)(4) with a pool of 2 samples and it passed.The customer reported that they will send next low samples to be tested on another platform.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• Brand Name: ACCESS VITAMIN B12 COBALAMIN
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 14711061
• MDR Text Key: 294620898
• Report Number: 9680746-2022-00002
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)230131(11)220131(10)272031
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 272031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/24/2022
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2022
• 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 Outcome(s): Other