MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BIL-D

Catalog Number 05589061190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/06/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable dbili direct bilirubin gen.2 results for 1 patient sample on a cobas integra 400 plus module compared to a beckman analyzer.On (b)(6) 2022, the initial dbili result was 5.65 mg/dl.The result was reported outside of the laboratory.The doctor questioned the result as it did not match the patient's clinical picture and the sample was repeated the next day.On (b)(6) 2022, the sample was repeated and the result was 5.37 mg/dl.The sample was sent to another lab and tested on a beckman analyzer on the same day.The beckman analyzer result was 3.70 mg/dl.The beckman analyzer result was deemed correct.The integra 400 plus analyzer serial number is (b)(4).

Manufacturer Narrative

The customer did not perform qc on the day of the event.It was previously performed on (b)(6) 2022 and was acceptable.Calibration was last performed on (b)(6) 2022.The alarm trace showed several no fluid detected and clot detected alarms.The patient sample was found to be icteric.The investigation is ongoing.

Manufacturer Narrative

The investigation determined there were no interfering substances in the patient sample.The investigation did not identify a product problem.

• Brand Name: BIL-D
• Type of Device: NA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15995026
• MDR Text Key: 308442029
• Report Number: 1823260-2022-04036
• Device Sequence Number: 1
• Product Code: CIG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123965
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 05589061190
• Device Lot Number: 60631701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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
• Treatment: FOLIC ACID; HYDROXYUREA; MORPHINE; THILATYL DIPYRONE
• Patient Sex: Male