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

Catalog Number 11776193122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned results for 1 patient sample tested for elecsys ca 19-9 immunoassay (ca 19-9).The customer observed that the ca 19-9 results became higher as the dilution factor increased.The initial ca 19-9 result was above the measurement range.The actual result was not provided.The result with a 2x dilution was 1300 u/ml.The result with a 5x dilution was 1400 u/ml.The application specialist visited the customer site and performed manual and instrument dilution tests on the sample.The results received by the application specialist were erroneous.It is not known if these results were being used for diagnostic purposes or if erroneous results were reported outside of the laboratory.Refer to the attached data for the results obtained by the application specialist.No adverse event occurred.The e601 analyzer serial number was not provided.The customer is not requesting any further investigation.The recommended dilution factor is 1:10.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.The investigation stated that the ca 19-9 assay aggregates due to the complex molecule structure.Single samples may not produce linear values during dilution.It is likely that this sample fits that description.

• Brand Name: ELECSYS CA 19-9 IMMUNOASSAY
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6033385
• MDR Text Key: 57629452
• Report Number: 1823260-2016-01576
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 11776193122
• Device Lot Number: 188632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1