MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).The patient age was also provided as (b)(6).A clarification has been requested.The full facility name was provided as (b)(6).Phone number was provided as "(b)(6)".

Event Description

The customer stated that they received an erroneous result for one patient sample tested for ferritin on the e602 analyzer.The sample initially resulted as 33.29 ug/l and this value was reported outside of the laboratory.The result was questioned by the clinician since it did not fit with previous results for the patient.The initial result was also said to not fit a subsequent result.The sample was repeated with an automatic dilution, resulting as 6177 ug/l.The patient was not adversely affected.The ferritin reagent lot number and expiration date were asked for, but not provided.The field service engineer replaced pinch valve tubings and a valve.He also performed preventive maintenance on the analyzer, including running a fishing line through the sipper flow path, reagent probe, and tubing.He performed a "system volume".Controls were run for all assays and these were ok.He found that a fuse was blown and he replaced this, but it blew again.He replaced a printed circuit board within the analyzer.

Manufacturer Narrative

The patient's date of birth of (b)(6) 1985 has been confirmed to be correct, so the patient was (b)(6) at the time of the event.

Manufacturer Narrative

The result of 6177 g/l was believed to be correct, as the patient has a history of having a high ferritin.A specific root cause could not be determined based on the provided information.The most likely root cause would be related to pre-analytic handling of the sample.A general reagent issue can most likely be excluded.The event was not reproducible.

• Brand Name: COBAS 8000 E602 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: 5735619
• MDR Text Key: 47748094
• Report Number: 1823260-2016-00785
• Device Sequence Number: 0
• Product Code: JMG
• Reporter Country Code: UK
• PMA/PMN Number: K100853
• 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 a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/20/2016
• 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: 30 YR