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 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Pt#1; pt#2; (b)(6) years; (b)(6) years; female; male.There was no additional patient information provided by the customer.Device evaluation: the evaluation of the customer issue for similar complaints by lot number could not be performed as the lot number is unknown.A review for trends by product code found no trends related to this issue.A review of labeling found the issue is adequately addressed.A review of the capa database found no trend was identified for the customer's issue.Based on all available information no product deficiency was identified.

Event Description

On (b)(6) 2020 customer provide additional information regarding their statement of false elevated architect lactate dehydrogenase (ldh) assay results for 2 patients.The customer provided: pt#1: (b)(6) year old female: initial = 195 u/l; repeat 714, 200 u/l; pt#2: (b)(6) year old male: initial = 244 u/l; repeat 331 u/l, 276 u/l (ref range: 140 to 280 u/l).It was also added that all results are from the same sample measured without further sample treatment.There was no impact to patient management reported.

• 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: 10248374
• MDR Text Key: 198549519
• Report Number: 3016438761-2020-00116
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/08/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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