MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) LACTATE DEHYDROGENASE

Model Number	2P56-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information, no specific patient information provided.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a falsely elevated architect ldh result of 337 u/l was generated for a patient sample that retested at 151 u/l on the same architect analyzer and 132/136 u/l on a different architect analyzer.The customer's normal range is 125 to 220 u/l.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
This incident was inadvertently submitted under the incorrect suspect medical device manufacturing site.The error was discovered on june 10, 2020.Mdr number 3002809144-2020-00471 was submitted to correct the manufacturing site from irving, texas to wiesbaden, germany.
Additional Manufacturer Narrative
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, a review of product quality history, and a review of product labeling.The ticket searches determined there were no other complaints similar to the current complaint issue and the tracking and trending report review determined that there are no related trends.Return testing was not completed as returns were not available.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
Additional Manufacturer Narrative
Correction to section d.Suspect medical device was discovered on (b)(6) 2020.The catalog# was submitted as 02p56-42 but should be 02p56-21 (irving, texas manufacturing site).

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9752912
• Report Number: 1628664-2020-00079
• Device Sequence Number: 740927
• Product Code: CFG
• UDI-Device Identifier: 00380740161477
• UDI-Public: 00380740161477
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/05/2020

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: 08/22/2020
• Device Model Number: 2P56-42
• Device Catalogue Number: 02P56-21
• Device Lot Number: 04294UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 06/10/2020; 06/10/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/26/2020; 06/11/2020; 07/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C16000 ANALYZER.; ARCHITECT C16000 ANALYZER.; ARCHITECT C16000 ANALYZER.; ARCHITECT C16000 ANALYZER.; LN 03L77-01 SN (B)(6).; LN 03L77-01 SN (B)(6).; LN 03L77-01 SN (B)(6).; LN 03L77-01 SN (B)(6).