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

Catalog Number	07528582190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).On 07-dec-2023, before the event, level 1 qc was acceptable; level 2 qc initially failed and upon repeating was acceptable.After the discrepant results were identified, both levels of qc failed.On (b)(6) 2023 qc was run on the same reagent pack and both levels of qc were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned low results for 110 patient samples tested for hdlc4 on a cobas 8000 c 702 module.Due to the low results, the customer repeated the patient samples.Of the data provided, the results for 4 patient samples were discrepant.Patient 1 initial result was 28 mg/dl.The repeat result was 51 mg/dl.Patient 2 initial result was 30 mg/dl.The repeat result was 53 mg/dl.Patient 3 initial result was 26 mg/dl.The repeat result was 54 mg/dl.Patient 4 initial result was 22 mg/dl.The repeat result was 46 mg/dl.
Additional Manufacturer Narrative
An abnormal aspiration alarm was observed on the alarm trace data from (b)(6) 2023.The sample draw volume of 2.5 ml may be too low.The field service engineer (fse) checked the instrument.No actions were taken other than replacing the reagent with a new pack from the same lot number.Based on a review of worldwide data of qc recovery for the reagent/control lot combination used by the customer, no reagent issue was found.It appears that replacing the reagent pack resolved the issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: 18367266
• Report Number: 1823260-2023-04143
• Device Sequence Number: 12784593
• 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): 02/22/2024

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: 02/28/2025
• Device Catalogue Number: 07528582190
• Device Lot Number: 714617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/22/2024
• 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