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	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated lactate dehydrogenase (ldh) result for one patient on an architect c16000 analyzer.The following data was provided (customer's reference range is 125-220 u/l): sample id (b)(6) initial result, on (b)(6) 2020, was 301.48 u/l, repeated on an architect c8000 was 187.08 u/l.The sample is then rerun on the c16000 analyzer and the result was 178.14 u/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated lactate dehydrogenase (ldh) result included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.A review of tickets determined that there is normal complaint activity for reagent lot 18818un19.Trending review determined no adverse trends for the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.No systemic issue or deficiency of the architect ldh assay was identified.Based on the information provided and abbott diagnostics' complaint investigation, no product deficiency 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: 10292402
• Report Number: 3002809144-2020-00697
• Device Sequence Number: 13690972
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/31/2020

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: 10/03/2020
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 18818UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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 PROCESSING MODULE,; ARCHITECT C16000 PROCESSING MODULE,; LIST# 03L77-01, SERIAL# (B)(6); LIST# 03L77-01, SERIAL# (B)(6)