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

Model Number	33000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 12263693
• Report Number: 9680746-2021-00050
• Device Sequence Number: 14602399
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)220131(11)210131(10)172011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190298
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1