MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PCT BRAHMS ELECSYS COBAS; PCT BRAHMS ASSAY

Catalog Number 09318747190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

The e801 analyzer serial numbers were (b)(6) (analyzer 1) and(b)(6) (analyzer 2).Calibration and qc were acceptable.

Event Description

The initial reporter complained of discrepant results for 2 patient samples tested for pct brahms elecsys cobas (pct) between 2 cobas e 801 analytical units.Patient 1 initial result from analyzer 1 was > 100 ng/ml.The sample was repeated on analyzer 2, resulting in 12.9 ng/ml.The initial result was compatible with the patient¿s previous pct result of 152.4 ng/ml.The customer repeated the sample on analyzer 2 and the result was > 100 ng/ml.The customer performed a 1/3 dilution and obtained a result of 3.97 ng/ml (calculated result 11.91 ng/ml).On (b)(6) 2023 the sample was repeated again on analyzer 2 and the result was > 100 ng/ml with a data flag.The customer is questioning the low result from analyzer 2.Patient 2 initial result from analyzer 2 was > 100 ng/ml.The result from analyzer 1 was 0.131 ng/ml.The sample was repeated on analyzer 1 with a result of 0.132 ng/ml.The sample was repeated on analyzer 2 with a result of 0.133 ng/ml.The high results were believed to be correct.

Manufacturer Narrative

Calibration and qc were acceptable.For analyzer 1: 84 sample-related alarms were observed.For analyzer 2: 63 sample-related alarms were observed.Based on the number of sample-related alarms, the event for patient 1 was likely due to a sample quality or tubing issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: PCT BRAHMS ELECSYS COBAS
• Type of Device: PCT BRAHMS ASSAY
• 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: 17502968
• MDR Text Key: 321713367
• Report Number: 1823260-2023-02582
• Device Sequence Number: 1
• Product Code: NTM
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K173927
• 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: 10/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 09318747190
• Device Lot Number: 595005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/12/2023
• 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