MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable results for one patient sample tested with the elecsys ca 15-3 ii assay.The sample was initially tested (b)(6) 2016 at 11:16 am with a result of 40.42 u/ml.That evening the quality controls failed.On (b)(6) 2016 the sample was tested 3 times with results of 22.09, 21.91, and 24.92 u/ml.Results of about 22 u/ml were reported outside the laboratory.Since the patient had previous results of 40 u/ml and 30.36 u/ml the customer tested a sample from the patient drawn on (b)(6) 2016.The ca 15-3 result was 40 u/ml.The patient was not adversely affected.The ca 15-3 reagent lot number was 152800; the expiration date was requested but not provided.

Manufacturer Narrative

The sample from (b)(6) 2016 was sent to the manufacturer for testing.Testing was performed by the manufacturer on 2 analyzers and replicated the customer's results.The investigation determined no quality controls were performed on 10/13/2016.The investigation was unable to determine the root cause of the event.Inadequate sample preparation of the 10/13/2016 sample, leading to incomplete clotting or microclots, is a possible cause of the lower results in the (b)(6) 2016 sample.A general product problem was excluded.

• Brand Name: COBAS 6000 E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6060826
• MDR Text Key: 58535031
• Report Number: 1823260-2016-01648
• Device Sequence Number: 0
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• 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