MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT B12 REAGENT KIT; RADIOASSAY, VITAMIN B12

Model Number	7K61-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect b12 result on a patient.Results provided: (b)(6) 2021, sid (b)(6)= 364 pg/ml< repeated on (b)(6) 2021 = 274 pg/ml (both results using lot# 23108ui00).Normal range: 345-1485 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect b12 result on a patient.Results provided: (b)(6) 2021, sid (b)(6)= 364 pg/ml< repeated on (b)(6) 2021 = 274 pg/ml (both results using lot# 23108ui00).Normal range: 345-1485 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed to architect i2000sr, list 3m74 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2022-00047-01.All further information will be documented under mdr number 3016438761-2022-00047-01.

• Brand Name: ARCHITECT B12 REAGENT KIT
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 13176978
• Report Number: 3005094123-2022-00005
• Device Sequence Number: 14574209
• Product Code: CDD
• UDI-Device Identifier: 00380740014193
• UDI-Public: 00380740014193
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K121314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 10/02/2021
• Device Model Number: 7K61-37
• Device Catalogue Number: 07K61-37
• Device Lot Number: 23108UI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC I2000SR INST, 03M74-02, ISR61701; ARC I2000SR INST, 03M74-02, ISR61701
• Patient Sex: Unknown