MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I B12 REAGENT KIT; RADIOASSAY, VITAMIN B12

Catalog Number 07P67-32

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i b12 results for one sample.The following data was provided (customer¿s normal range: 140 to 650 pmol/l): sid (b)(6) initial result = 325 pmol/l, repeat = 220 pmol/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7p67-32 has a similar product distributed in the us, list number 7p67-21/-31.

Event Description

The customer observed falsely elevated alinity i b12 results for one sample.The following data was provided (customer¿s normal range: 140 to 650 pmol/l): sid (b)(6) initial result = 325 pmol/l, repeat = 220 pmol/l.No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from alinity i b12 reagent kit, list number 07p67-32, longford to alinity i processing module, 03r65-01, irving ia/cc.Mdr number 3016438761-2023-00586-00 has been submitted and all further information will be documented under that mdr number.Section g1 has been updated to current contact information.H3 other text : after further evaluation, the suspect medical device was changed from alinity i b12 reagent kit, list number 07p67-32, longford to alinity i processing module, 03r65-01, irving ia/cc.Mdr number 3016438761-2023-00586-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY I B12 REAGENT KIT
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17766252
• MDR Text Key: 324244607
• Report Number: 3005094123-2023-00248
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K121314
• 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,Followup
• Report Date: 11/08/2023

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: 12/23/2023
• Device Catalogue Number: 07P67-32
• Device Lot Number: 49132UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)