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	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Patient identifier: complete entry = (b)(6).Patient information: no further patient information was provided.
Event or Problem Description
The customer reported a falsely elevated architect lactate dehydrogenase result.Sample id (b)(6) generated 470 and retest of 89 u/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the customer's issue included a review of the complaint text, a search for similar complaints, review of manufacturing records and labeling.Return testing was not completed as returns were not available.Review of complaint activity determined that there was normal complaint activity for reagent lot 04431un19.Review of tracking and trending reports did not identify any related trends for the architect lactate dehydrogenase assay.Manufacturing documentation for the assay did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.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: 9119103
• Report Number: 1628664-2019-00635
• Device Sequence Number: 16792275
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/13/2019

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: 01/07/2020
• Device Catalogue Number: 02P56-21
• Device Lot Number: 04431UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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 C4000, LIST 02P24-40.; ARCHITECT C4000, LIST 02P24-40.; SERIAL (B)(4).; SERIAL (B)(4).