MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDLC4

Catalog Number 07528566190

Device Problem High Test Results (2457)

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

Event Date 09/26/2023

Event Type  malfunction  

Event 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. .

Manufacturer Narrative

The serial number of the customer's cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 326254086
• Report Number: 1823260-2023-03329
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07528566190
• Device Lot Number: 688046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female