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	03/09/2020
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.Section a.Patient information: no further patient information was provided by the customer.
Event or Problem Description
The customer observed erratic architect lactate dehydrogenase (ldh) assay results for one patient sample.Sample id (b)(6) was tested multiple times across two analyzers.The sample generated elevated results of 295.96 and 258.68 u/l and normal results of 210.55 u/l, 199.29 and 187.71 u/l.The customers reference range is 125 to 220 u/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Investigation of the customer issue included a review of the complaint text, review of complaint activity, review of manufacturing documentation and labeling review.Return testing was not completed as returns were not available.The customer indicated inspection of the sample showed small suspended particles.Review of complaint activity associated with reagent lot 33529un19 identified one other related complaint.Review of tracking and trending reports associated with the lactate dehydrogenase assay did not identify any related trends.Manufacturing documentation associated with the reagent lot did not identify any issues.Additionally, labeling was reviewed which sufficiently addresses the customers issue.Based on the investigation no systemic issue or deficiency of the architect lactate dehydrogenase assay was identified.

• 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: 9877741
• Report Number: 3016438761-2020-00012
• Device Sequence Number: 19622043
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 07/04/2020
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 33529UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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, LIST 01G06-11,; ARCHITECT C8000, LIST 01G06-11,; LIST 03L77-01, SERIAL (B)(6) ; LIST 03L77-01, SERIAL (B)(6) ; SERIAL (B)(6) , ARCHITECT C16000,; SERIAL (B)(6) , ARCHITECT C16000,