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

Model Number	2P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10176543
• Report Number: 3016438761-2020-00098
• Device Sequence Number: 1073279
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000 PROCESSING MODULE,; ARCHITECT C8000 PROCESSING MODULE,; LIST# 01G06-11, SERIAL# (B)(6); LIST# 01G06-11, SERIAL# (B)(6)