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 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned high results for 1 patient tested for elecsys ca 19-9 immunoassay (ca 19-9).The customer thinks there may be an interferent in the sample and sent the sample in for investigation.During the investigation, erroneous results were identified between the customer¿s cobas 8000 core unit, an e 602 analyzer used at the investigation site and the lumipulse method.It is not known if the customer reported the high result outside of the laboratory.The results from the investigation will be provided to the customer.In (b)(6) 2016, the patient¿s ca 19-9 result was 40 u/ml.On (b)(6) 2016 the patient had a result of 4631 u/ml.Since this result was suddenly elevated, the customer suspected an interference and requested an investigation of the sample.Refer to the attached data for the results obtained during the investigation.A neuraminidase test on the sample was also performed.Refer to the attached data for the results from the sample before it was treated with neuraminidase and after it was treated with neuraminidase.No adverse event occurred.The customer¿s 8000 core unit serial number was (b)(4).The e602 analyzer serial number used at the investigation site was (b)(4).The ca 19-9 reagent lot number used at the investigation site was 188632 with and expiration date of 05/2017.The ca 19-9 results were different between the different manufacturers, however, both assays indicate the ca 19-9 results are high.The discrepancy may be due to the different set up of each assay and the different antibodies affecting test results.

Manufacturer Narrative

An interference was not identified during the investigation.Based upon the information provided for investigation, the ca 19-9 results are believed to be correct.Although the results were different between the two manufacturers, both assays indicate high ca 19-9 results.

• 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: 6025444
• MDR Text Key: 57314350
• Report Number: 1823260-2016-01556
• 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: 11/22/2016

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: 133102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• 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
• Patient Age: 82 YR