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

Model Number	LDL-C G3
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch initial reporter name and address: (b)(6).
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ldl_c ldl-cholesterol plus 3rd generation on a cobas 8000 c 702 module.No incorrect results were reported outside of the laboratory.The sample was initially tested on the c 702 analyzer, resulting in an ldl value of 3.5 mmol/l.The sample was repeated on a hitachi 7600 competitor system, resulting in an ldl value of 17.38 mmol/l.The serial number of the c 702 analyzer was requested, but not provided.
Additional Manufacturer Narrative
The patient has alagille syndrome which involves liver disease (cholestasis).Since the liver is impaired in the disease state of cholestasis, the measurement of hdl and ldl is of no medical value.The values measured for ldl may be interfered with by bilirubin because the cholestasis goes along with elevated levels of bilirubin depending on the disease stage.The investigation could not identify a product problem.

• Brand Name: LDLC3
• Common Device Name: LOW DENSITY LIPOPROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15715739
• Report Number: 1823260-2022-03466
• Device Sequence Number: 6620293
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143691
• 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): 12/13/2022

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 Model Number: LDL-C G3
• Device Catalogue Number: 07005768190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/13/2022
• 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 Age: 12 MO
• Patient Sex: Male