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 Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received a erroneous results for one patient sample tested for carbohydrate antigen 19-9 ((b)(4)) on an elecsys analyzer.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The sample initially resulted as 294.8 u/ml when tested on the customer's elecsys analyzer.The sample was provided for investigation where it was tested on an e411 analyzer, resulting as 296.6 u/ml.The sample was also tested using the lumipulse method, resulting as 394 u/ml.The patient was not adversely affected.The elecsys analyzer model and serial number used at the customer site was asked for, but not provided.The e411 analyzer used for investigation was serial number (b)(4).Ca 19-9 reagent lot number 188632, with an expiration date of 05/01/2017 was used on this analyzer.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Investigations conclude that results showed the same tendency with both methods.The reason for the increase in the patient results remain unknown.Further clinical examination and monitoring of the patient should be taken into consideration.

• 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: 5700316
• MDR Text Key: 46570268
• Report Number: 1823260-2016-00723
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 11776193122
• Device Lot Number: 188632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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: 70 YR