MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CYFRA 21-1; CYTOKERATIN FRAGMENTS 21-1 EIA

Catalog Number 11820966122

Device Problem High Test Results (2457)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 - cobas e 602 module is 1342-19.The investigation reviewed the calibration data.The calibration performed on (b)(6) 2023 showed that calibration signals for calibrator level 1 were within the expected range, but were below for calibrator level 2.The calibration performed on (b)(6) 2023 using the affected reagent pack showed that calibration signals for calibrator level 1 were above the expected range, but far below the expected range for calibrator level 2; the affected reagent pack seems to be not well calibrated.The investigation reviewed the customer's qc results.The results were within range but close to -2.5 standard deviations (sd) on (b)(6) 2023 for level 2.The investigation reviewed the alarm trace; two (2) "abnormal sample aspiration" alarms were found on (b)(6) 2023.The investigation reviewed pictures of the affected reagent pack; there was no obvious damage to the reagent pack.The investigation determined the customer's action (replacing the reagent pack) resolved the issue.A general reagent problem can be excluded because another reagent pack of the same lot performed according to specifications at the customer¿s and at other customers¿ sites.The cause of the event could not be determined. .

Event Description

The initial reporter received questionable elecsys cyfra 21-1 (cyfra 21-1) results from three patient samples tested on the cobas 8000 - cobas e 602 module.The initial results were not reported outside of the laboratory.The reporter stated that the results from the affected reagent pack were higher and were not clinically suitable compared to the results from the new reagent pack with the same lot number.The affected reagent pack was recalibrated; qc passed but the patient results were still abnormal.The (b)(6) 2023 initial results were obtained from the affected reagent pack.The (b)(6) 2023 first repeat results were obtained from a new reagent pack.The (b)(6) 2023 second repeat results were obtained from the affected reagent pack after recalibration and qc.Sample id (b)(6).On (b)(6) 2023, the initial result was 85.97 ng/ml.On (b)(6) 2023, the first repeat result was 2.77 ng/ml.On (b)(6) 2023, the second repeat result was 57.28 ng/ml.Sample id (b)(6).On (b)(6) 2023, the initial result was 122.6 ng/ml.On (b)(6) 2023, the first repeat result was 2.63 ng/ml.On (b)(6) 2023, the second repeat result was 184.5 ng/ml.Sample id (b)(6).On (b)(6) 2023, the initial result was 365.9 ng/ml.On (b)(6) 2023, the first repeat result was 3.59 ng/ml.On (b)(6) 2023, the second repeat result was 416.8 ng/ml.

• Brand Name: ELECSYS CYFRA 21-1
• Type of Device: CYTOKERATIN FRAGMENTS 21-1 EIA
• 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: 18150404
• MDR Text Key: 329706796
• Report Number: 1823260-2023-03631
• Device Sequence Number: 1
• Product Code: OVK
• Combination Product (y/n): Y
• Reporter Country Code: VM
• PMA/PMN Number: K160915
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11820966122
• Device Lot Number: 71131001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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