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

Catalog Number 07528582190

Device Problems High Test Results (2457); Output Problem (3005)

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

Event Date 09/16/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 324976296
• Report Number: 1823260-2023-03194
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942572
• UDI-Public: 04015630942572
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K162593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07528582190
• Device Lot Number: 711952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male