MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	08056960190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned low results not corresponding to the clinical picture for 1 patient tested for cobas c bilirubin total gen.3 (bilt3) on a cobas integra 400 plus analyzer and a c503 analyzer used at a different site.The patient is being tested at the customer site with normal bilt3 results.Different samples from this patient were tested at a different site using a competitor method and the total bilirubin results were high.On (b)(6) 2024 the result from the 400 plus analyzer was 0.8 mg/dl.On (b)(6)2024 the repeat result from a c503 analyzer at a different site was 0.7 mg/dl.On (b)(6) 2024 the results from the competitor method were 4.1 mg/dl and 4.1 mg/dl.On (b)(6) 2024 the result from the competitor method was 3.8 mg/dl.On (b)(6) 2024 the result from the competitor method was 3.3 mg/dl.On (b)(6) 2024 a new sample was obtained and the result from the 400 plus analyzer was 0.7 mg/dl.On (b)(6) 2024 this sample was repeated on a c503 analyzer with a result of 0.660 mg/dl.
Additional Manufacturer Narrative
The integra 400 plus serial number is(b)(6).The c503 analyzer serial number was not provided.The competitor method is beckman coulter.The patient sample was brown in appearance.Sample material was requested for investigation.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the syringes and checked and cleaned the rotor.The fse ran precision and mechanical checks with acceptable results.No instrument issues were identified.Calibration was last performed on 15-feb-2024 with acceptable results.Incomplete qc data was provided.The customer used a centrifugation time of 5 minutes.This time may be too short based on the manufacturer's recommendations."no fluid detected", "critical value" and "clot detected" alarms were observed during a review of the alarm trace data.These alarms are indicators of possible poor sample quality.Sample material from the patient is no longer available for investigation.The investigation determined the event was consistent with an issue with the patient sample.As sample material is no longer available, the cause of the event could not be determined.

• Brand Name: COBAS C BILIRUBIN TOTAL GEN.3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 18959779
• Report Number: 1823260-2024-00866
• Device Sequence Number: 11907056
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131544
• 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): 05/31/2024

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: 12/31/2024
• Device Catalogue Number: 08056960190
• Device Lot Number: 71751001
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACYCLOVIR; COMPAZINE ¿ EVERY 6 HRS AS NEEDED; CYCLOSPORINE; ELTROMBOPAG ¿ 150 MG 1X/DAY; MAGNESIUM GLYCINATE ¿ 2X/DAY; MODAFINIL ¿ 1X/DAY; NEORAL ¿ 2X/DAY; SUMATRIPTAN ¿ AS NEEDED; TRAZADONE ¿ 1X/DAY; VITAMIN B12
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 69 KG