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

Catalog Number	07K61-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H3 other text : an evaluation is in process.
Event or Problem Description
The customer observed an elevated result while using the architect b12 assay.The customer provided the following data (pg/ml): sid (b)(4).Initial (b)(6) 2017: 522 retests: (b)(6) 2017: 303 and 4/15/17: 281.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, design history record review, and a review of labeling.An accuracy testing protocol was executed using lot 70399ui00; testing met the acceptance criteria and determined the reagent is performing acceptably.Tracking and trending did not identify an adverse trend for the lot in question.The design history record review did not identify any events or issues that would have impacted the performance of the lot in question.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect b12 assay, list 07k61, lot 70399ui00, was identified.

• Brand Name: ARCHITECT B12
• Common Device Name: VITAMIN B12
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 6553872
• Report Number: 3005094123-2017-00020
• Device Sequence Number: 1170434
• Product Code: CDD
• UDI-Device Identifier: 00380740014179
• UDI-Public: 00380740014179
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2017
• Device Catalogue Number: 07K61-27
• Device Lot Number: 70399UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4).