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	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable lactate dehydrogenase acc.Ifcc ver.2 result from the cobas c 303 analytical unit for one patient.The initial result on a c501 instrument was 192 u/l.The following were repeat results on the c303 instrument: the first repeat result was 932 u/l.The second repeat result was 584 u/l.The third repeat result was 569 u/l.On (b)(6) 2025, the fourth repeat result was 196 u/l.On (b)(6) 2025, the fifth repeat result was 201 u/l.On (b)(6) 2025, the sixth repeat result with a dilution of 1:2 was 103 u/l.
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The qc and calibration were passing at the time of the event.This indicates that a general reagent issue is not likely.In the alarm trace report, some abnormal aspiration errors were noted.The investigation determined that the root cause is consistent with improper sample handling and/or contamination with erythrocytes, leading to elevated lactate dehydrogenase results.There is no product issue found.

• 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: 23531911
• Report Number: 1823260-2025-04596
• Device Sequence Number: 9047666
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/18/2025

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: 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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