MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT LACTATE DEHYDROGENASE2; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Catalog Number 04T03-20

Device Problem Installation-Related Problem (2965)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The customer reported falsely elevated architect lactate dehydrogenase2 and provided the following data: reference range: 125 - 220 u/l.Sample id #(b)(6).Original result: >1465.Repeat diluted: 141.3.Repeated neat again: 150.7.Repeated diluted: 143.4.It was reported that when the field service engineer (fse) installed the assay file, the undiluted protocol was selected and integration was performed using the undiluted protocol rather than the diluted protocol.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

Manufacturer Narrative

E1 phone: complete phone number is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any no non-conformances, potential non-conformances, or deviations with the complaint lot.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency of the architect lactate dehydrogenase2 reagent lot 57160ud00 was identified.

Event Description

The customer reported falsely elevated architect lactate dehydrogenase2 and provided the following data: reference range: 125 - 220 u/l.Sample id #(b)(6) original result: >1465 repeat diluted: 141.3 repeated neat again: 150.7 repeated diluted: 143.4 it was reported that when the field service engineer (fse) installed the assay file, the undiluted protocol was selected and integration was performed using the undiluted protocol rather than the diluted protocol.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

• Brand Name: ARCHITECT LACTATE DEHYDROGENASE2
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• 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: 18711996
• MDR Text Key: 335810453
• Report Number: 3005094123-2024-00062
• Device Sequence Number: 1
• Product Code: CFJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/11/2024

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: 04T03-20
• Device Lot Number: 57160UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C403338; ARC C4000 INTGR, 02P24-40, C403338