MAUDE Adverse Event Report: ABBOTT LABORATORIES LACTATE DEHYDROGENASE (LDH); NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number 2P56-21

Device Problem High Test Results (2457)

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

Event Date 11/21/2021

Event Type  malfunction  

Event Description

The customer observed falsely elevated ldh results generated on the architect c16000 processing module.The following results were provided (reference range 125 to 243 u/l): sid (b)(6) initial result was 893 u/l, no repeat result provided.Sid (b)(6) initial result was 872 u/l, no repeat result provided.Sid (b)(6) initial result was 905 u/l, no repeat result provided.No impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected information can be found in section d4 catalogue number, changed from 02p56-21 to 02p56-22.

Manufacturer Narrative

A search by lot number did not find elevated complaint activity.Return testing was not completed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 81714un21 and the complaint issue.The customer found foam in the bottle and determined that was the likely cause for elevated results.As part of troubleshooting, the r2 bottle was replaced, the sample was retested, and results obtained were within range.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the cc ldh reagent lot 81714un21 was identified.Corrected data found in section g1.

• Brand Name: LACTATE DEHYDROGENASE (LDH)
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12915576
• MDR Text Key: 284027198
• Report Number: 1415939-2021-00051
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/24/2022

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: 01/12/2022
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-22
• Device Lot Number: 81714UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 01/04/2022
• Supplement Dates FDA Received: 12/16/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1602141; ARC C16K PRC MOD, 03L77-01, C1602141; ARC C16K PRC MOD, 03L77-01, C1602141