MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II ASSAY; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 03045838122

Device Problem High Test Results (2457)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of discrepant high results for 3 patient samples tested for elecsys ca 15-3 ii (ca15-3 ii) assay on a cobas 8000 e 602 module with a serial number of (b)(4).On (b)(6) 2017 a field service representative received a set of ca15-3 ii reagent from the customer where the magnetic particles had adhered to the lid of the reagent.On (b)(6) 2017 the customer obtained a calibration for ca15-3 ii that was on the low side (calibration factor of 1.00).On (b)(6) 2017 the customer tried performing a calibration for a new set of ca15-3 ii reagent but received errors due to differences from previous calibration (calibration factor greater than 1.2).A field service representative visited the customer and a new ca15-3ii reagent set was calibrated without error (calibration factor of 1.57) and the control results were normal.The customer decided to repeat patient samples that were near the cutoff and that was when the discrepant results were obtained for 3 patient samples.For patient #1 the initial ca15-3 ii was 29.3 u/ml with a repeat result of 18.33 u/ml.For patient #2 the initial ca15-3 ii was 32.7 u/ml with a repeat result of 19.7 u/ml.For patient #3 the initial ca15-3 ii was 43.7 u/ml with a repeat result of 27.14 u/ml.The initial ca15-3 ii results were reported outside of the laboratory and corrected reports had to issued.There was no allegation of an adverse event.

Manufacturer Narrative

The field service representative finding of magnetic beads adhering to the lid of the ca15-3 ii reagent is the likely cause of the issue.A general reagent problem is excluded.

Manufacturer Narrative

Based on the data and information that was provided, an assay related issue could not be detected.

• Brand Name: ELECSYS CA 15-3 II ASSAY
• Type of Device: TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
• 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: 7087199
• MDR Text Key: 95078283
• Report Number: 1823260-2017-02858
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K010588
• 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,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 03045838122
• Device Lot Number: 20990003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• 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