MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING ATM) LACTATE DEHYDROGENASE

Model Number	2P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was previously reported under mdr number 3002809144-2020-00096, for which an error was identified with the manufacturer name (abbott gmbh) and an incorrect list number (02p56-42).This mdr is being submitted to correct the manufacturer name to abbott laboratories (irving/atm) and to correct the list number from 02p56-42 to 02p56-21.All available patient information has been included.No additional patient details are available.An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, and a review of product labeling.Ticket searches did not identify any other complaints similar to the current complaint issue.No trends were identified.No other issues were identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
Event or Problem Description
The customer reported a false elevated lactate dehydrogenase (ldh) result when processing on the architect c16000.The initial result was 514 u/l and retest was 198 u/l.Retesting on another instrument yielded results of 195, 7, and 197 u/l.The customer uses a reference range of 125-220 u/l.No impact to patient management was reported.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING ATM); 1921 hurd drive; irving TX 75038
• MDR Report Key: 9910387
• Report Number: 1628664-2020-00109
• Device Sequence Number: 3387966
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2020
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: 40988UN19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1