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 Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of erroneous results for 2 patient samples tested for elecsys (b)(6) assay (b)(6) on a cobas 6000 e 601 module.The erroneous results were reported outside of the laboratory.Patient id (b)(6) initial (b)(6) result on the e601 module was 6.99 ui/l.This result was reported outside of the laboratory.On (b)(6) 2017 the sample was repeated on a cobas e 411 immunoassay analyzer and the result was >60 (unit of measure not provided).On (b)(6) 2017 the sample was repeated on the e601 module and the result was 60.00 ui/l with a >test flag.Patient id (b)(6) initial (b)(6) result on the e601 module was 6.02 ui/l.This result was reported outside of the laboratory.On (b)(6) 2017 the sample was repeated on the e411 analyzer and the result was >60 (unit of measure not provided).There was no allegation that an adverse event occurred.The (b)(6) reagent lot number was 182889.The expiration date was not provided.The customer's calibration signals were well within the acceptable range.

Manufacturer Narrative

Both patient samples were submitted for investigation.The anti-hav results of >60.00 iu/l from the customer's e411 analyzer were reproduced on an e411 and an e601 used at the investigation site.The customer's low anti-hav results from the e601 module were not reproduced.Possible root causes for the high results may be related to improper pre-analytical handling and/or contamination, foam on the reagent or clotting time.A specific root cause was not identified.Additional information was requested for investigation but was not provided.

• 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: 6676489
• MDR Text Key: 78728281
• Report Number: 1823260-2017-01363
• Device Sequence Number: 0
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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: 06/09/2017
• 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