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 08/28/2020

Event Type  malfunction  

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 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.

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
• Type of Device: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10546937
• MDR Text Key: 241004223
• Report Number: 3002809144-2020-00933
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C803666; ARCHITECT C8000 SYSTEM, LN 01G06-11,; SERIAL # (B)(6)