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

Model Number	HDL-C GEN.4
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1823260-2022-00671
• Device Sequence Number: 17410500
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/14/2022
• 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 Sex: Unknown