MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE

Model Number	2P56-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information, 1.Patient identifier = (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely elevated ldh results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2020 sid (b)(6) initial = 570 u/l (normal range 120-240 u/l) / retested = 193 and 207 u/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
The customer reported falsely elevated results while using lactate dehydrogenase on the architect processing module c803666.Return testing was not completed as returns were not available.The trend review by the product list number (ln 02p56-22) found no trends related to this issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the lactate dehydrogenase assay, list number 02p56-22, was identified.

• 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: 10546937
• Report Number: 3002809144-2020-00933
• Device Sequence Number: 19616750
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• 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): 11/12/2020

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 Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: ARC C8 PROC MOD, 01G06-11, C803666; ARCHITECT C8000 SYSTEM, LN 01G06-11,; SERIAL # (B)(6)