MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE (LDH); NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number 2P56-22

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

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.Reporter phone complete entry = (b)(6).Reporter postal code had leading zero added to meet minimum field requirement.

Event Description

The customer observed a falsely elevated lactate dehydrogenase (ldh) result for one patient on an architect c8000 analyzer.The following data was provided (customer¿s reference range is 125-220 u/l): initial result was 491, repeats were 200 and 212 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.Trending review determined no related trends for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Manufacturing documentation for the likely cause list number was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of lactate dehydrogenase (ldh) assay, list number 02p56-22, was identified.

• Brand Name: LACTATE DEHYDROGENASE (LDH)
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12532492
• MDR Text Key: 277996705
• Report Number: 3002809144-2021-00581
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/29/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C803904; ARC C8 PROC MOD, 01G06-11, C803904