MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY LACTATE DEHYDROGENASE2; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Catalog Number 04T99-30

Device Problem High Test Results (2457)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c ldh results for one patient.The following data was provided (reference range: 125-220 u/l): ac01723.(b)(6) 2022, (b)(6) ldh2 535 u/l (high), repeated on another instrument (data not available) (b)(6) 2022, (b)(6) ldh2 476 u/l (high), repeated on another instrument (data not available) two additional sids were provided ((b)(6)), however, no values were provided.No impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 39506ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Labelling review concludes that the issue is adequately addressed.In house accuracy testing was performed using retained reagent file samples of lot 39506ud00.The testing results met acceptance criteria and the product is performing as expected.Based on all reviewed data, we conclude that there is no product deficiency with the alinity lactate dehydrogenase2 reagent identified in this complaint.Corrected information found in section d4.Catalogue number changed to 04t99-30.

• Brand Name: ALINITY 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: 15528642
• MDR Text Key: 302366244
• Report Number: 3005094123-2022-00210
• Device Sequence Number: 1
• Product Code: CFJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• 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: 11/22/2022

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: 03/25/2023
• Device Catalogue Number: 04T99-30
• Device Lot Number: 39506UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)