MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE

Model Number 2P56-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2019

Event Type  malfunction  

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 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.

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
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9474001
• MDR Text Key: 219840015
• Report Number: 1628664-2019-00761
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 33529UN19
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 ANALYZER.; ARCHITECT C16000 ANALYZER.; LN 03L77-01 SN (B)(6).; LN 03L77-01 SN (B)(6).