MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.Note: this event is also being reported in manufacturer report 1628664-2019-00762 under a second suspect medical device.
Event or Problem Description
The customer observed a falsely elevated lactate dehydrogenase (ldh) result on the architect c16000 analyzer.The following data was provided: sid (b)(6) initial 976, repeats 179, 180.There was no impact to patient management reported.
Additional Manufacturer Narrative
The suspect medical device was removed as a likely cause.The product evaluation and all follow up information will be provided in the architect c16000 analyzer ln 03l77-01 sn (b)(6) manufacturers report 1628664-2019-00762.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9474001
• Report Number: 1628664-2019-00761
• Device Sequence Number: 19397860
• Product Code: CFJ
• 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): 02/12/2020

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 Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 33529UN19
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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 C16000 ANALYZER.; ARCHITECT C16000 ANALYZER.; LN 03L77-01 SN (B)(6).; LN 03L77-01 SN (B)(6).