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

Model Number	33000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The access vitamin b12 reagent was not returned for evaluation.A beckman coulter field service engineer was dispatched to the customer site and completed routine troubleshooting activities but did not identify any system or hardware issues that would have contributed to the issue.An assignable cause for the questioned results cannot be determined due to insufficient information.
Event or Problem Description
The customer reported obtaining non-reproducible vitamin b12 (access vitamin b12) patient results on their unicel dxi 800 access immunoassay system (s/n: (b)(4)).The customers patient results were lower than the normal range of the assay.Ten patient samples were sent to an alternate facility for testing and nine of the samples recovered within the normal range of the assay.One patient sample was reproducible and recovered low on repeat.There was a change in patient treatment.An unknown number of patients were administered vitamin b12 injections based on the false low vitamin b12 results.Quality controls (qc) recovered intermittently in and out of specifications.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS VITAMIN B12 REAGENT
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghan's mills; clare ; EI
• MDR Report Key: 7984456
• Report Number: 9680746-2018-01000
• Device Sequence Number: 1395269
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)190331(11)180331(10)871058
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 10/19/2018

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: 03/31/2019
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 871058
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 10/19/2018
• 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