MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AFP ELECSYS COBAS E 100 V2; ALPHA-FETOPROTEIN TEST FOR TESTICULAR CANCER

Catalog Number 07645694700

Device Problems High Test Results (2457); Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e602 immunoanalyzer serial number was (b)(6).The field service engineer found that the flocculent was floating causing turbidity in the procell syringe.The fse also found that there was an obvious flocculent adhesion in the procell cup.The fse cleaned the instrument, the sipper needle and the black tube.Investigaion is ongoing.

Event Description

We received an allegation about discrepant results for 5 patients' sample tested with elecsys afp assay on a cobas 8000 cobas e602 immunoassay analyzer.Sample 1 (patient 1): initial result: more than 1000 with a data flag.Rerun result: 4.71 the patient performed a ct scan and no abnormalities were found.The physician called and requested the sample to be repeated.The rerun result was deemed to be correct.Sample 2 (patient 2): initial result: 424.1 rerun result: 2.48 sample 3 (patient 3): initial result: 455.8 rerun result: 1.98 sample 4 (patient 4): initial result: 663.6 rerun result: 11.57 sample (patient 5): initial result: 582.8 rerun result: 5.94 the unit of measurement was not provided.

Manufacturer Narrative

The investigation did not identify a product problem.The root cause of the event was consistent with a contamination issue.The service action (cleaning the instrument) resolved the issue.No further issues were reported afterward.

• Brand Name: AFP ELECSYS COBAS E 100 V2
• Type of Device: ALPHA-FETOPROTEIN TEST FOR TESTICULAR CANCER
• 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: 17728461
• MDR Text Key: 323166744
• Report Number: 1823260-2023-02950
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K220176
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07645694700
• Device Lot Number: 670629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• 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
• Patient Sex: Male
• Patient Race: Asian