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

Catalog Number 11776193122

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys ca 19-9 immunoassay results for one patient compared to the results they received from lumipulse analyzer.(b)(6).This sample was submitted for investigation and was tested on cobas 6000 e 601 module serial number (b)(4) on (b)(6) 2017.The results were 1.56 u/ml and 1.22 u/ml.The reagent lot in use for this testing was 193941 with expiration date 05/01/2018.The results were reported to the clinician.There was no allegation of an adverse event.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.A possible cause was the use of different ca19-9 antibodies in the different manufacturer's assays as the different antibodies presumably recognize different parts of the molecule.It is known that the ca 19-9 results for a patient¿s sample can vary depending on the testing procedure used.Ca 19-9 values determined on patient samples by different testing procedures cannot be directly compared with one another.This information id documented in product labeling for the assay.There is no international standard available for ca19-9.A general reagent issue was excluded as the reagents used for investigation performed acceptably and no similar complaints have been reported.

• 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: 6737251
• MDR Text Key: 81139135
• Report Number: 1823260-2017-01517
• 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,Followup
• Report Date: 09/06/2017

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 Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 07/04/2017
• Supplement Dates FDA Received: 09/06/2017
• 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