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

Catalog Number	03004732122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lactate dehydrogenate (ldhi gen.2) results from the cobas 6000 c 501 analyzer.The customer was switching to a new lot of reagent and performed a patient comparison.The samples were repeated on another cobas 6000 c 501 using new reagent lot 747707.The customer did not know which result was correct.Patient 1 initial result was 377 u/l and the repeat result was 245 u/l.Patient 2 initial result was 260 u/l and the repeat result was 153 u/l.Patient 3 initial result was 390 u/l and the repeat result was 245 u/l.Patient 4 initial result was 262 u/l and the repeat result was 153 u/l.
Additional Manufacturer Narrative
The cobas 6000 c 501 analyzer serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field application specialist performed calibration and repeated the patient comparisons using reagent lots 747707 and 773098.The comparison was acceptable.The analyzer alarm trace contained multiple alarms indicating issues with sample quality.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: 18979865
• Report Number: 1823260-2024-00911
• Device Sequence Number: 6570723
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 03004732122
• Device Lot Number: 72604101
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/06/2024
• 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 Age: 15 YR
• Patient Sex: Female