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

Catalog Number	08057958190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase acc.Ifcc ver.2 results for 1 patient sample on a cobas pure c 303 analytical unit.The initial result was 348 u/l.The customer questioned the initial result as it was inconsistent with the patient's previous result.The sample was repeated three times and the results were 163 u/l, 169 u/l, and 167 u/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
It was found that the customer was centrifuging one sample tube type for 15 minutes at 1800 g, which may be too long of a time, and another sample tube type for 3 minutes at 2900 g, which may be too short of a time.The root cause of the event was found to be consistent with pre-analytical sample handling issues.The investigation did not identify a product problem.

• 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: 23596614
• Report Number: 1823260-2025-04718
• Device Sequence Number: 18761409
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/06/2026

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 Catalogue Number: 08057958190
• Device Lot Number: 91805601
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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