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

Model Number LDL-C G3

Device Problem Incorrect Measurement (1383)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

Medwatch initial reporter name and address: (b)(6).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 307212376
• Report Number: 1823260-2022-03466
• Device Sequence Number: 1
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Male