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

Catalog Number 11776193122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for carbohydrate antigen 19-9 (ca 19-9) 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 241.5 u/ml.When diluted times 5, the sample resulted as 703.4 u/ml.When diluted times 10, the sample resulted as 1110.0 u/ml.The sample results were said to be non-linear.The patient was not adversely affected.The elecsys analyzer model and serial number were asked for, but not provided.

Manufacturer Narrative

The patient has a history of gastric polyp.The patient sample was provided for investigations where it was tested on a cobas 8000 analyzer.The sample resulted as 230.0 u/ml when run on the cobas 8000 analyzer.The sample was manually diluted times 2, resulting with a raw value 180.3 u/ml and resulting with a final value of 361 u/ml when accounting for the dilution factor.The sample was manually diluted times 5, resulting with a raw value 138.3 u/ml and resulting with a final value of 692 u/ml when accounting for the dilution factor.The sample was manually diluted times 10, resulting with a raw value 101.2 u/ml and resulting with a final value of 1012 u/ml when accounting for the dilution factor.When the sample was tested for neuraminidase recovery, it resulted as 230.5 u/ml before ca 19-9 and as 1.22 u/ml after ca 19-9.The sample was diluted times 10 and tested for neuraminidase recovery where it resulted as 103.6 u/ml before ca 19-9 and as 1.38 u/ml after ca 19-9.The cobas 8000 analyzer used in investigations was serial number (b)(4).Ca 19-9 reagent lot number 188632, with an expiration date of may 2017 was used on this analyzer.

Manufacturer Narrative

Investigations conclude that non linear dilution behavior of the sample could be verified.The ca 19-9 antigen tends to aggregate and this may lead to non linear dilution behavior in certain samples.This limitation is covered in product labeling.

• 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: 5700438
• MDR Text Key: 46583483
• Report Number: 1823260-2016-00725
• 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,Followup
• Report Date: 07/06/2016

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: 188632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/22/2016; 07/06/2016
• 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: 62 YR