MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION IMMUNOGLOBULIN M; IGM, ANTIGEN, ANTISERUM, CONTROL

Catalog Number 09P63-24

Device Problem Installation-Related Problem (2965)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 - patient identifier = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely decreased immunoglobulin m on the alinity c processing module for one patient.The following results were provided: sid (b)(6) - initial run (standard 1:5 dilution) = >16.9 g/l, automatic rerun of undiluted sample = 1.045 g/l; rerun with 1:20 manual dilution = 40.724 g/l.Configuration of the assay in the alinity c software was performed in august 2023.If the analyzer is configured as g/l the range would be 0-0.25 and if configured as mg/dl the range would be 0-25.The units of measure were entered as g/l, but the range was not updated to 0-0.25 g/l.The analyzer configuration of the rerun rule was to perform an automatic rerun of an undiluted sample if the value fell within the range configured in the software.Since the alinity software was configured with a range of 0-25 g/l, the automatic rerun protocol was incorrect, and the sample was repeated as an undiluted sample.The sample needed to be diluted prior to rerunning.There was no impact to patient management reported.

Event Description

The customer reported a falsely decreased immunoglobulin m on the alinity c processing module for one patient.The following results were provided: sid (b)(6) initial run (standard 1:5 dilution) = >16.9 g/l, automatic rerun of undiluted sample = 1.045 g/l; rerun with 1:20 manual dilution = 40.724 g/l configuration of the assay in the alinity c software was performed in august 2023.If the analyzer is configured as g/l the range would be 0-0.25 and if configured as mg/dl the range would be 0-25.The units of measure were entered as g/l, but the range was not updated to 0-0.25 g/l.The analyzer configuration of the rerun rule was to perform an automatic rerun of an undiluted sample if the value fell within the range configured in the software.Since the alinity software was configured with a range of 0-25 g/l, the automatic rerun protocol was incorrect, and the sample was repeated as an undiluted sample.The sample needed to be diluted prior to rerunning.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer confirm the complaint issue without indication for any additional issues identified.A search for similar complaints did not identify an increase in complaint activity for lot 60053ud00.Ticket trending review did not identify any trends for the issue for the product.A device history record review did not identify any nonconformances or deviations associated with lot 60053ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the immunoglobulin m (igm) reagent for lot 60053ud00 was identified.

• Brand Name: IMMUNOGLOBULIN M
• Type of Device: IGM, ANTIGEN, ANTISERUM, CONTROL
• 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: 19070813
• MDR Text Key: 340679718
• Report Number: 3005094123-2024-00177
• Device Sequence Number: 1
• Product Code: DFT
• UDI-Device Identifier: 00380740169916
• UDI-Public: (01)00380740169916(17)241130(10)60053UD00
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K983132
• 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: 05/24/2024

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 Catalogue Number: 09P63-24
• Device Lot Number: 60053UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01476; ALNTY C PROCESSING MODU, 03R67-01, AC01476