MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE

Catalog Number 02P56-21

Device Problem High Test Results (2457)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1415939-2019-00014.The incorrect manufacturing location was documented.This report was generated to document (b)(6) as the manufacture location.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated lactate dehygrogenase (ldh) result while using the clinical chemistry ldh assay.The customer indicated the patient was admitted after the initial result was generated.The following results were provided: initial 1154, retest results: 214, 209 and 215 u/l no impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, instrument log review, a search for similar complaints, and a review of labeling.Return material was not available.Instrument log file review did not identify an instrument issue.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available no product deficiency of the clinical chemistry lactate dehydrgenase assay, reagent list number 02p56, lot number 73199un18, was identified.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8478584
• MDR Text Key: 140784734
• Report Number: 1628664-2019-00286
• 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: 07/15/2019

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: 05/07/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 73199UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 PROCESS MODULE; ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(6); LN 01G06-11, SN (B)(6); ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4)