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	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase acc.Ifcc ver.2 results for approximately 10% of all patient samples tested on a cobas c 503 analytical unit.One example was provided.The initial result was 540 u/l with a data flag.The repeated results were 366 u/l with a data flag, 0.78 u/l, 235 u/l, 567 u/l, 636 u/l, and 294 u/l.The sample was re-centrifuged and retested.The results were 206 u/l and 208 u/l.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).A precision test was performed with the alleged sample.All of the results had data flags.The results were 344 u/l, 348 u/l, 348 u/l, 345 u/l, 348 u/l, 346 u/l, 346 u/l, 348 u/l, 349 u/l, 348 u/l, 347 u/l, 348 u/l, 348 u/l, 349 u/l, and 346 u/l.Multiple samples were returned for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Another example of a patient sample with alleged questionable results for lactate dehydrogenase acc.Ifcc ver.2 was provided.Patient 2: on (b)(6) 2026, the initial result was 297 u/l, and the repeated result was 211 u/l.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general product problem was excluded.The returned samples were all extremely clotted.Two samples were hemolyzed.The returned samples were centrifuged and investigated.The customer's issue could not be confirmed during the investigation.The investigation determined the issue was due to pre-analytical handling issues at the customer site.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: 24316329
• Report Number: 1823260-2026-00483
• Device Sequence Number: 17353028
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/07/2026

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: 929874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/18/2026; 04/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/16/2026; 05/07/2026
• 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