MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

Catalog Number 02P56-21

Device Problem High Test Results (2457)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated architect ldh results on id (b)(6) of 558, 184 and 256 u/l.The account uses a normal ldh range of 125 to 220 u/l.No impact to patient management was reported.No specific patient information was provided.

Manufacturer Narrative

Quality control results were reported as ok when a precision run was done.A review of the ldh qc results for (b)(6) to (b)(6) 2019 show within control assay precision.No atypical complaint trends or non-conformance were identified related for the ldh assay results.The ldh assay package insert has extensive information on the need for correct sample preparation.For plasma samples, sufficient centrifugation is necessary to remove platelets and other cellular materials that may impact ldh results.Plasma samples may benefit from the 1:3 dilution provided in the assay parameter file to help decrease the impact of platelets on ldh analyses.To optimize plasma analysis, the package insert states samples may be transferred to a secondary sample tube after centrifugation.Based on the complaint information and the package insert labeling, the most likely cause for the initially elevated ldh results are related to the sample preparation process.The labeling describes cellular debris or platelets as having a likely impact to patient results.With qc material lacking these components, there would be no impact on those samples.Use error may have contributed to the customer issue as insufficient sample collection or preparation is a likely cause of the initially elevated sample results.Trend review and lot search did not identify an increase in complaint activity for the current issue.No customer returns were available for evaluation.No product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8442431
• MDR Text Key: 139713841
• Report Number: 1628664-2019-00237
• 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: 07/16/2019

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: 08/08/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 38576UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000, LN 01G06-11; ARCHITECT C8000, LN 01G06-11; SERIAL (B)(6); SERIAL (B)(6)