MAUDE Adverse Event Report: ABBOTT GMBH 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
(b)(4).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.
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
Correction to section d.Suspect medical device was discovered on (b)(6) 2020.The catalog# was submitted as 02p56-42 (wiesbaden, germany manufacturing site) but should be 02p56-21 (irving, texas manufacturing site).See mdr # 1628664-2020-00079 for the correct manufacturing site.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10146006
• Report Number: 3002809144-2020-00471
• Device Sequence Number: 2438522
• 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
• Report Date (Section B): 07/03/2020

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: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/03/2020
• 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; LN 03L77-01 SN (B)(4); LN 03L77-01 SN (B)(6)