MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDLC4

Catalog Number	07528566190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable hdlc4 hdl-cholesterol plus 4th generation (hdl) result from one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The doctor questioned the result which prompted the rerun of the patient sample.The initial result was 115 mg/dl.The repeat result was 36 mg/dl.The repeat result was deemed correct. .
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 19-oct-2023; the results were within specifications.The investigation reviewed the qc recovery; the results were within specifications.There is no indication of a performance issue with the reagent.The investigation reviewed the alarm trace.There were multiple "abnormal aspiration" alarms noted on the date of the event close to the time the sample was processed.The field service engineer inspected the module and performed a 21-cup precision test and hardware check with unsuccessful results.He then adjusted the gear pump pressure from 280 to 310/320.He verified the module's performance with another 21-cup precision test with successful results.The fse determined that the event was caused by the low gear pump pressure.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: HDLC4
• Common Device Name: HDL
• 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: 17951424
• Report Number: 1823260-2023-03329
• Device Sequence Number: 7530449
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 07528566190
• Device Lot Number: 688046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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 Age: 67 YR
• Patient Sex: Female