MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDLC4; HIGH DENSITY LIPOPROTEIN TEST SYSTEM

Catalog Number	07528582190
Medical Device Problem Codes	High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The quality control results were acceptable.Therefore a general reagent problem could be ruled out.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable hdlc4 results from the cobas 8000 c702 module.The first result was 113.7 mg/dl and the repeat results on another system were 37.7 mg/dl and 37.8 mg/dl.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration was last performed on 13-sep-2023 with acceptable results.A general reagent issue can be excluded as calibration and qc were acceptable.The alarm trace showed frequent abnormal aspiration alarms.Based on the frequent abnormal aspiration alarms, the root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: HDLC4
• Common Device Name: HIGH DENSITY LIPOPROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17875853
• Report Number: 1823260-2023-03194
• Device Sequence Number: 12558326
• Product Code: LBS
• UDI-Device Identifier: 04015630942572
• UDI-Public: 04015630942572
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K162593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 09/30/2024
• Device Catalogue Number: 07528582190
• Device Lot Number: 711952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 64 YR
• Patient Sex: Male