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 Type  malfunction  

Manufacturer Narrative

Patient identifier: multiple = (b)(6).All there is no further patient information provided due to privacy issues.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated ldh results on one patient generated on the architect analyzer.The results provided were: sid (b)(6) initial plasma sample = 418u/l / repeat = 236u/l; sid (b)(6) serum sample = 264 / 270u/l.There was no reported impact to patient management.

Manufacturer Narrative

Instrument logs were pulled for the customer instrument.The quality control (qc) appears to be performing as expected during the time the complaint was registered indicating the reagent was performing as expected at that time.A review of all complaints associated with the ldh assay (list number 2p56, lot number 12577un18) and a review for complaint trends and corrective actions for the list number was performed.The review did not identify any trends or non-conformances associated with this issue.Additionally, labeling was reviewed and adequately addresses the issue under review.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: 8471262
• MDR Text Key: 140610371
• Report Number: 1628664-2019-00277
• 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: 08/13/2019

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: 12577UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM, LN 03L77-01; ARCHITECT C16000 SYSTEM, LN 03L77-01; SERIAL # (B)(4); SERIAL (B)(4)