MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT B12; VITAMIN B12

Catalog Number 07K61-35

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information: patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 07k61-35 that has a similar product distributed in the us, list number 07k61-37.Ticket searches for lot 85398ui00 identified normal complaint activity.Complaint trending reports were reviewed, and no trends were identified associated with the complaint issue.Using worldwide field data the historical performance in the field of lot 85398ui00 was reviewed.The patient median result for the lot was within established limits and comparable to other reagent lots in the field.Manufacturing documentation for the complaint lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect b12 assay was identified.

Event Description

The customer observed a false elevated architect b12 result for 1 patient.Sample id (b)(6), (b)(6) 2018 initial result = 1070 pmol/l (1449.9 pg/ml) the sample was retest (date unknown) and generated 161 pmol/l (218.2 pg/ml).There was no impact to patient management reported.

• Brand Name: ARCHITECT B12
• Type of Device: VITAMIN B12
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 8893750
• MDR Text Key: 160039472
• Report Number: 3005094123-2019-00224
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K110579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Catalogue Number: 07K61-35
• Device Lot Number: 85398UI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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