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

Catalog Number 07005768190

Device Problem Non Reproducible Results (4029)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for ldl-cholesterol gen.3 (ldlc3) on a cobas 8000 c 702 module.The initial result was 69.1 mg/dl.This result was reported outside of the laboratory where the patient complained.On (b)(6) 2023 the sample was repeated with a result of 143.3 mg/dl.

Manufacturer Narrative

The c702 module serial number was (b)(6).Calibration and qc were acceptable.The field service engineer (fse) performed a system decontamination.The investigation is ongoing.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The customer complained of discrepant results for an additional patient sample tested for hdlc4: on 19-oct-2023 the initial hdl result was 64.1 mg/dl.The repeat result was 164.7 mg/dl.The ldlc3 reagent lot number was 68806301 with an expiration date of 31-oct-2024.The hdlc4 reagent lot number was 704172 with an expiration date of 31-dec-2024.

Manufacturer Narrative

For hdlc4: calibration and qc were acceptable.Based on the calibration and qc data, general reagent issues were excluded.The customer did not provide any additional information related to the instrument.The customer has had no further issues.Based on the information provided, the cause of the event could not be determined.The investigation did 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17694243
• MDR Text Key: 322778190
• Report Number: 1823260-2023-02902
• Device Sequence Number: 1
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (y/n): Y
• Reporter Country Code: RO
• PMA/PMN Number: K100853
• 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,Followup
• Report Date: 11/30/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07005768190
• Device Lot Number: 68806301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• 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