MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) LACTATE DEHYDROGENASE

Model Number 2P56-21

Device Problem High Test Results (2457)

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

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information, 1.Patient identifier = sid (b)(6).There was no additional patient information provided.A review of tickets determined that there is normal complaint activity for lot 04294un19.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.Retesting of the sample gave expected normal results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the lactate dehydrogenase (ldh) reagent, lot 04294un19 was identified.

Event Description

The customer reported falsely elevated lactate dehydrogenase (ldh) results on one patient.The results provided were: on (b)(6) 2020 sid (b)(6) initial = >665u/l (normal range 125-200u/l); 1:1 = 220 / 1:10 = 186u/l.There was no reported impact to patient management.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10385217
• MDR Text Key: 232825114
• Report Number: 3016438761-2020-00165
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2020

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 Expiration Date: 08/22/2020
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 04294UN19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1