MAUDE Adverse Event Report: A.I.D.D LONGFORD 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 10/10/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated lactate dehydrogenase (ld/ldh) results on architect c16000 processing module for two patients.The results provided were: sid (b)(6) heparin=260 u/l and 190 u/l / result on serum=159 u/l /repeated on architect c16001490=379 u/l.Sid (b)(6) initial=308 u/l /repeated on c1601490=387 u/l, 222 u/l and 266 u/l /repeated on (b)(6)c1601491=672 u/l and 681 u/l /repeated on c1601490=692 u/l and 687 u/l.Laboratory reference range for ldh= < 245 u/l the precision data provided for troubleshooting purpose.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for patient identifier (b)(6).Updated postal code (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 review of product quality history.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 trending review of available complaint data for the complaint list number did not identify any trend regarding commonalities for lot number and issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the product quality history for the lot number did not identify issues associated with the customer¿s observation.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the architect ldh2 reagent lot number 41177ud00 was identified.

• Brand Name: ARCHITECT LACTATE DEHYDROGENASE2
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15668297
• MDR Text Key: 303667721
• Report Number: 3005094123-2022-00230
• Device Sequence Number: 1
• Product Code: CFJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Catalogue Number: 04T03-20
• Device Lot Number: 41177UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01,(B)(6)