MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; 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 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable carbohydrate antigen 19-9 results for one patient when compared to other platforms.The data provided for the patient was: during a medical checkup, the result was "the upper normal range".In "bio medika", the result was 30.96 u/ml.In lab 1 with a cobas e601 analyzer, the result was 32 u/ml.The patient was checked again and the result on a siemens analyzer was 62 u/ml.In lab 2 with a cobas e601 analyzer, the result was 27 u/ml.In another laboratory with an unknown analyzer, the result was 53.5 u/ml.Information regarding if all of the results were from the same sample was requested, but was not provided.Information regarding if any erroneous results was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.The serial number (b)(4) was provided, but it was not clear which cobas e601 this was.The serial number of the other cobas e601 was requested, but was not provided.

Manufacturer Narrative

Additional information was provided that the results from the different labs were tested from different sample tubes drawn from the same patient on different dates.The testing was performed in different counties such as (b)(4).For the result from "(b)(4)", a cobas e 601 analyzer was used.The customer is unclear as to which result is correct.

Manufacturer Narrative

A specific root cause could not be identified.Based on the provided, the results between roche analyzers were stable and comparable.Review of the provided calibration and qc data did not indicate any analyzer or reagent issue.Ca 19-9 results can vary when the same sample is tested with different assays from different manufacturer's and cannot be directly compared with one another.This difference is documented in product labeling.It is recommended to continue with one method for monitoring of the patient, or running several parallel measurements with the same sample on the different methods to confirm if the differences between the methods remain stable.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5673221
• MDR Text Key: 45704405
• Report Number: 1823260-2016-00677
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• 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: 18863203
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• 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