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

Catalog Number	08057958190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number (module 1) was (b)(6).The analyzer's serial number (module 2) was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase acc.Ifcc ver.2 results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 1248 u/l with a data flag.The sample was automatically diluted, and the result was 168 u/l.The initial result and the result after the dilution were obtained on module 1.The sample was repeated on another module (module 2), and the results were 257 u/l and 170 u/l.The result of 257 u/l was questioned due to it not matching the patient's clinical history.
Additional Manufacturer Narrative
The qc was acceptable.A general product problem was excluded.A pre-analytical handling issue could not be excluded.Due to lack of information, the investigation could not identify a specific cause of the event.The investigation did not identify a product problem.
Additional Manufacturer Narrative
H6 investigation conclusion code was updated.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23880474
• Report Number: 1823260-2025-05328
• Device Sequence Number: 4669692
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 04/27/2026

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: 05/31/2026
• Device Catalogue Number: 08057958190
• Device Lot Number: 87699601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/22/2026; 04/07/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/16/2026; 04/27/2026
• 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