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

Catalog Number 04T03-20

Device Problem High Test Results (2457)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The customer reported a falsely elevated architect lactate dehydrogenase2 result for one sample.The following data was provided: sid (b)(6): initial result = > 1465 u/l (reference range: 125-220 u/l).Repeat result using auto-dilution 1:3 = 322.1 u/l.Repeat result undiluted = 205.3 and 192.5 u/l.Specimen type: plasma, collected in lithium heparin separator tube.All qc was in range.The architect lactate dehydrogenase2 package insert for plasma specimens, the customer should be running the std 1:3 protocol.Customer is running the "undiluted" protocol.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.There was no impact to patient management reported.

Manufacturer Narrative

A1 - patient identifier: (b)(6) (complete patient identifier).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated architect lactate dehydrogenase2 result for one sample.The following data was provided: sid (b)(6): initial result = > 1465 u/l (reference range: 125-220 u/l).Repeat result using auto-dilution 1:3 = 322.1 u/l.Repeat result undiluted = 205.3 and 192.5 u/l.Specimen type: plasma, collected in lithium heparin separator tube.All qc was in range.The architect lactate dehydrogenase2 package insert for plasma specimens, the customer should be running the std 1:3 protocol.Customer is running the "undiluted" protocol.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.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, 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 reagent lot performs as expected for this product.A review of ticket trending data for architect lactate dehydrogenase2 was performed and did not identify any trends regarding the commonalities for the issue under review.A review of the device history record did not identify any issues associated with the customer¿s observation.Labeling was reviewed and adequately addresses the complaint issue.However, the root cause was identified as the customer was using undiluted protocol in plasma sample and it was advised to follow up package insert instructions in specimen collection and preparation for analysis, which is stated as std 1:3 protocol should be used in plasma samples due to platelets and other cellular aggregates interference during pre-analytical procedures.After completion of the service team instructions the results were obtained as expected and qc was noted as in range and precision was acceptable.Based on the investigation, architect lactate dehydrogenase2 reagent lot 55517ud00 is performing as intended, no systemic issue or product deficiency was identified.

• 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: 18717393
• MDR Text Key: 335809828
• Report Number: 3005094123-2024-00065
• 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: 03/05/2024

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: 55517UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• 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, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6)