MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE DEHYDROGENASE ACC. IFCC VER.2; LACTATE DEHYDROGENASE TEST SYSTEM

Catalog Number	08057958190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The field service engineer adjusted the rinse unit, cleaned the rinse unit tubing and probes, and ran a precision check.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase acc.Ifcc ver.2 results for one patient sample on a cobas c 503 analytical unit.The initial result was 501 mg/dl.The repeat result was 383 mg/dl.The initial result was questioned as it did not match the patient's medical history.
Additional Manufacturer Narrative
The analyzer alarm trace contained numerous abnormal aspiration alarms.Therefore, the investigation determined the issue was consistent with pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.A hardware-related issue could not be ruled out as the issue appeared to be resolved after the service actions.The investigation did not identify a specific cause of the event.

• Brand Name: LACTATE DEHYDROGENASE ACC. IFCC VER.2
• Common Device Name: LACTATE DEHYDROGENASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20892840
• Report Number: 1823260-2024-03591
• Device Sequence Number: 8709756
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K964457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 06/30/2025
• Device Catalogue Number: 08057958190
• Device Lot Number: 80428901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown