MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number 07027028214

Device Problems Product Quality Problem (1506); High Test Results (2457); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

There was an allegation of a questionable ca 19-9 elecsys e2g result from the cobas e 801 analytical unit.The initial result was 186 u/ml.The patient questionable the result and the sample was repeated on (b)(6) 2024 with a result of 10.7 u/ml.

Manufacturer Narrative

The cobas e 801 analytical unit serial number was (b)(6).The qc results were acceptable.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The specific cause of the event could not be determined.A general reagent problem was not present, because the qc prior to the event was within ranges.The analyzer alarm race contained no conspicuous messages hinting at a root cause.

• Brand Name: ELECSYS CA 19-9
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 18636172
• MDR Text Key: 334491117
• Report Number: 1823260-2024-00312
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K050231
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027028214
• Device Lot Number: 708245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian