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

Catalog Number 03004732122

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The cobas 6000 c 501 analyzer serial number was (b)(6).The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 338617806
• Report Number: 1823260-2024-00911
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K964457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female