MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE

Catalog Number	02P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
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.No additional patient information was provided.
Event or Problem Description
The customer reported falsely elevated architect lactate dehydrogenase results on the alinity c analyzer.Sample id (b)(6) generated an initial result of 657 and when repeated 193 ui/l.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The initial manufacturer report was inadvertently submitted with an incorrect analyzer type (alinity c analyzer) documented.The correct instrument is architect c16000 analyzer.Review of complaint activity did not identify any adverse or non-statistical trends for the architect lactate dehydrogenase assay.An increase in complaint activity was not identified for reagent lot 86459un18.The customer's instrument logs were reviewed.The questioned results were found to have been tested on the same reagent kit.The quality control logs were also reviewed and found the control results were within the expected ranges before and after the elevated patient results were generated.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, 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 MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8274021
• Report Number: 1628664-2019-00047
• Device Sequence Number: 16533188
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 04/05/2019

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: 06/11/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 86459UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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 C16000 ANALYZER, LN 03L77-01; ARCHITECT C16000 ANALYZER, LN 03L77-01; SERIAL # C1600945; SERIAL # C1600945