MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE; LACTATE DEHYGROGENASE

Catalog Number 02P56-21

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

This event was previously reported in manufacturer report number 1415939-2017-00093.The manufacturer location was incorrectly documented.This report is being filed.Further investigation of the customer issue included a review of the complaint text, inhouse testing, instrument log review, a search for similar complaints, and a review of labeling.Returned material was available but not returned.The assay files were successfully calibrated and each validity control replicate generated was within the established ranges demonstrating the reagent lot is performing within specification.A review of the instrument logs confirmed that an error code was generated during the timeframe the customer generated the discrepant result.This error could indicate the presence of bubbles, foam, or fibrin in the sample.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry lactate dehydrogenase (ldh) assay,ln 02p56, lot number 47146un15, was identified.

Event Description

The customer observed falsely elevated lactate dehygrogenase (ldh) results while using the clinical chemistry ldh assay.The customer provided the following results: patient 1: (no sid provided) initial 121, retest 93 sid: (b)(6), initial 641, retest 279 and 315, sid: (b)(6), initial 1286, retest 279 and 219, sid: (b)(6), initial 636, retest 251 and 251.No impact to patient management was reported.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYGROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8446018
• MDR Text Key: 139706828
• Report Number: 1628664-2019-00245
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2016
• Device Catalogue Number: 02P56-21
• Device Lot Number: 47146UN15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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