MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE DEHYDROGENASE; LACTATE DEHYDROGENASE ASSAY USING NAD/NADH

Catalog Number	03004732122
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase results from the cobas 6000 c501 module.The initial result was 629 u/l.The repeat results were 884 u/l and 427 u/l.The initial result was believed to be correct.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause.The issue was consistent with pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.An effect from the patient's beta-thalassemia could not be ruled out.There is no evidence to suggest a malfunction of the device.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE ASSAY USING NAD/NADH
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20261177
• Report Number: 1823260-2024-02714
• Device Sequence Number: 8931018
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• 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): 11/15/2024

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: 03004732122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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: Male