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	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned a discrepant high result for 1 patient sample tested for lactate dehydrogenase acc.Ifcc ver.2 (ldhi2) on a cobas c 503 analytical unit.The initial result was 653 u/l.The physician questioned this result.The sample was repeated on a different c503 analyzer with a result of 207 u/l.The sample was repeated on the original c503 analyzer with a result of 196 u/l.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
The investigation determined the issue was consistent with pre-analytical handling issues at the customer site.Improper sample handling and/or contamination with erythrocytes lead to elevated ldh results.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• 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: 23742238
• Report Number: 1823260-2025-04987
• Device Sequence Number: 8421295
• 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
• Report Date (Section B): 01/13/2026

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: 07/31/2026
• Device Catalogue Number: 08057958190
• Device Lot Number: 89812001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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