MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE

Catalog Number 02P56-41

Device Problem High Test Results (2457)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1415939-2017-00132.The incorrect manufacturing location was documented in the original report.This report was generated to document (b)(4) as the manufacture location.Further investigation of the customer issue included a review of the complaint text, an instrument log review, a search for similar complaints, and a review of labeling.The instrument log review indicated that the analyzer had generated error codes to indicate that aspiration errors had occurred.Additionally, it indicated that preventative maintenance was not performed (clean cuvettes) in (b)(6) 2017.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on the available information no deficiency of the clinical chemistry ldh assay, reagent list number 02p56, lot 80712un16, was identified.

Event Description

The customer observed falsely elevated lactate dehydrogenase (ldh) results while using the clinical chemistry ldh assay.The customer provided the following results: initial 1046, this result was questioned by the physician and testing was repeated retests: 187 and 192.No impact to patient management was reported.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE
• 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: 8446182
• MDR Text Key: 139714191
• Report Number: 1628664-2019-00247
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740101121
• UDI-Public: 380740101121
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 06/07/2017
• Device Catalogue Number: 02P56-41
• Device Lot Number: 80712UN16
• 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: 09/01/2016
• 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