MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-CHOLESTEROL GEN.4; HIGH DENSITY LIPOPROTEIN TEST

Catalog Number 08057877214

Device Problem Non Reproducible Results (4029)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable trigl triglycerides and hdlc3 hdl-cholesterol plus 3rd generation results for 2 patient samples on a cobas pure c 303 analytical unit.This medwatch will cover hdl.Refer to medwatch with a1 patient identifier (b)(6) for information on the trigl results.For sample 1, the initial hdlc3 result was 181 mg/dl.The repeat result was 39.4 mg/dl.For sample 2, the initial hdlc3 result was 126 mg/dl.The repeat result was 43.9 mg/dl.

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.Corrected patient result information was provided on (b)(6) 2024.The correct hdl repeat result for patient 1 was 193 mg/dl.The alarm trace did not contain a conspicuous event.The field service engineer (fse) changed and adjusted the gear pump head, rinsed the cuvettes, unclogged the rinse arm manifold, decontaminated the syringes, and adjusted the pipette and cuvette washes.Based on the available data, a general reagent issue could be excluded.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: HDL-CHOLESTEROL GEN.4
• Type of Device: HIGH DENSITY LIPOPROTEIN TEST
• 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: 18817805
• MDR Text Key: 336885430
• Report Number: 1823260-2024-00620
• Device Sequence Number: 1
• Product Code: LBS
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K220134
• 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: 04/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057877214
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1