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

Catalog Number	08057966190
Medical Device Problem Codes	Chemical Problem (2893); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ldlc3- (low density, lipoprotein) results from the cobas c 503 analytical unit.Patient 1: the initial result was 26 mg/dl.The same sample was repeated on another pro analyzer with a result of 27 mg/dl and on a c311 analyzer with a result of 22 mg/dl.The same sample was repeated on an abbott analyzer and the result was 87 mg/dl.Patient 2: ((b)(6) 2024): the initial result was 10 mg/dl.The same sample was repeated on another pro analyzer with a result of 11 mg/dl.The same sample was repeated on an abbott analyzer and the result was 119 mg/dl.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined.The investigation found n-acetly cysteine injections were administered.This interference is documented in product labeling for the assay "acetaminophen intoxications are frequently treated with n-acetylcysteine.N-acetylcysteine at the therapeutic concentration when used as an antidote and the acetaminophen metabolite n-acetyl-p-benzoquinone imine (napqi) independently may cause falsely low ldl-c results." the provided analyzer alarm trace contained numerous abnormal aspiration alarms which are indicators of preanalytic issues.Correct pre-analytic sample handling is within the customer's responsibility.Patient 2 had urosepsis which can influence ldl results.The investigation did not identify a product problem.

• 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: 20783786
• Report Number: 1823260-2024-03446
• Device Sequence Number: 8948936
• Product Code: MRR
• UDI-Device Identifier: 07613336121375
• UDI-Public: 07613336121375
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/23/2024

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: 08057966190
• Device Lot Number: 788409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1: 2.PAN; PATIENT 1: LOOZ SYRUP; PATIENT 1: N- ACETYL CYSTEINE; PATIENT 1: OPTINEURON; PATIENT 1: THYMINE; PATIENT 1: UDCA; PATIENT 1: URSOCAL; PATIENT 1:RIFAGUT; PATIENT 2: LINEZOLID; PATIENT 2: N- ACETYL CYSTEINE; PATIENT 2: PAN 40; PATIENT 2: QUETIAPINE; PATIENT 2: RIFAGUT; PATIENT 2: UTILIV
• Patient Sex: Unknown