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

Model Number 33000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).The access b12 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is insufficient evidence to suggest a reagent or hardware malfunction occurred in this event.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported that on (b)(6) 2021, erroneous low b12 results (access vitamin b12, part number 33000 and lot number 172011) were generated on the customer's dxi 800 (dxi 800 access immunoassay analyzer w/ spot b, part number a71456 and serial number (b)(4)) for an unknown number of patients.The initial low results were released from the laboratory.The customer reported a change to patient treatment for several patients; the patients were prescribed vitamin b 12 supplements (dosages not provided).The customer reported the low results were discordant with patients¿ clinical files.Customer also reported higher b12 results were obtained upon repeat for some patient samples (no data provided).System performance indicators such as system check, calibrations and quality control (qc) have been passing within specifications as reported by the customer.There were no issues with sample integrity reported by the customer.Sample collection and handling information such as sample type, volume drawn, transportation and handling, centrifugation, storage or other sample handling information was not provided by the customer.

• Brand Name: ACCESS VITAMIN B12 COBALAMIN
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 12263693
• MDR Text Key: 282205156
• Report Number: 9680746-2021-00050
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)220131(11)210131(10)172011
• Combination Product (y/n): N
• PMA/PMN Number: K190298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 08/02/2021

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: 01/31/2022
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 172011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1