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	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Section a.Patient information, no specific patient information provided.
Event or Problem Description
The customer reported a false elevated architect lactate dehydrogenase results for one sample.The sample (id 426 and 1426) generated an initial result of 933 u/ml, and retests of 623 and 206 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
A search for similar complaint was performed for architect lactate dehydrogenase (ldh) reagent lot 50494un18 and found no other complaint related to the current issue.Tracking and trending did not identify any trends associated.The customers instrument logs were reviewed.This review found the customer had switched the default 1:3 automated dilution in the assay settings to the no dilution mode.The package inserts state that the samples be run with the 1:3 automated dilution mode to reduce pre-analysis variance.After the correction was made quality control and patient samples were normal.Manufacturing documentation was reviewed and did not identify any issues associated with the complaint issue.Review of product labeling found adequate information regarding the issue.Based on the investigation, no systemic issue or product deficiency was identified for the ldh reagent.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8604963
• Report Number: 1628664-2019-00369
• Device Sequence Number: 13953108
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/24/2019

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: 11/05/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 50494UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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 LIST 03L77-01; ARCHITECT C16000 ANALYZER, LIST 03L77-01; SERIAL C1601659; SERIAL C1601659