MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-C GEN.4

Model Number HDL-C GEN.4

Device Problems Low Test Results (2458); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.The field service engineer performed a precision check for hdlc4 which passed within specifications.The customer resolved the issue by replacing the reagent onboard with a new cassette.Based on the data provided a clear root cause could not be identified.

Event Description

The initial reporter received questionable hdlc4 hdl-cholesterol plus 4th generation results for multiple patient samples with a cobas 6000 c501 module.The reporter stated they were receiving very low results but most were with data flags.They replaced the reagent pack, calibration and qc were acceptable and had no further issues.The following are examples of discrepant results for 7 patient samples that did not have data flags: sample 1: the initial result was 7 mg/dl.The repeated result was 37 mg/dl.Sample 2: the initial result was 3 mg/dl.The repeated result was 8 mg/dl.The second repeated result was 61 mg/dl.Sample 3: the initial result was 3 mg/dl.The repeated result was 40 mg/dl.Sample 4: the initial result was 5 mg/dl.The repeated result was 45 mg/dl.Sample 5: the initial result was 8 mg/dl.The repeated result was 59 mg/dl.Sample 6: the initial result was 7 mg/dl.The repeated result was 43 mg/dl.Sample 7: the initial result was 6 mg/dl.The repeated result was 42 mg/dl.The questionable results were reported outside of the laboratory.The cobas c501 serial number was (b)(4).

• Brand Name: HDL-C GEN.4
• Type of Device: HDL
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13756453
• MDR Text Key: 293446726
• Report Number: 1823260-2022-00671
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: HDL-C GEN.4
• Device Catalogue Number: 07528566190
• Device Lot Number: 53064501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• 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