MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE

Model Number 2P56-22

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

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 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.

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
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10292402
• MDR Text Key: 221286875
• Report Number: 3002809144-2020-00697
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 PROCESSING MODULE,; ARCHITECT C16000 PROCESSING MODULE,; LIST# 03L77-01, SERIAL# (B)(6); LIST# 03L77-01, SERIAL# (B)(6)