MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) LACTATE DEHYDROGENASE

Model Number 2P56-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated lactate dehydrogenase (ldh) results on one patient from an architect c8000 analyzer.The following data was provided: sample id (b)(6) initial result, on (b)(6) 2020, was 2441 u/l, which was reported out of the laboratory and questioned by the medical provider.When the sample was repeated the results were 308, 369, 359, and 312 u/l.There was no impact to patient management reported.

Manufacturer Narrative

Review of complaint activity associated with the complaint lot identified normal complaint activity.Review of tracking and trending reports for the lactate dehydrogenase (ldh) reagent did not identify any related trends.Return testing was not completed as returns were not available.Using worldwide field data, the performance of reagent lot 52827un19, and associated sublots, manufactured with the same material were evaluated and are performing similar to other reagent lots in the field confirming there was no systemic issue.Manufacturing documentation for the likely cause lots were reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the lactate dehydrogenase (ldh) reagent was identified.Based on the information provided and abbott diagnostics' complaint investigation, no product deficiency was identified.Correcting section d2.Product code from cfg to cfj.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10176543
• MDR Text Key: 225929909
• Report Number: 3016438761-2020-00098
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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: 11/21/2020
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 52827UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 PROCESSING MODULE,; ARCHITECT C8000 PROCESSING MODULE,; LIST# 01G06-11, SERIAL# (B)(6); LIST# 01G06-11, SERIAL# (B)(6)