MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDLC3; SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Catalog Number	08057966190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for ldlc3 on a cobas c 503 analytical unit.The initial result was 19.4 mg/dl.The sample was repeated due to a request from the clinician.The repeat result was 127 mg/dl.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The c503 analyzer number was 2058-03.
Additional Manufacturer Narrative
No further data was provided by the customer.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: LDLC3
• Common Device Name: SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
• 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: 17998131
• Report Number: 1823260-2023-03419
• Device Sequence Number: 5847018
• Product Code: MRR
• UDI-Device Identifier: 07613336121375
• UDI-Public: 07613336121375
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• PMA/510(K) Number: K012287
• 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): 11/14/2023

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: 08057966190
• Device Lot Number: ASKU
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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