MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem High Test Results (2457)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable elecsys ferritin result for one patient sample.The initial result was 88.80 ug/l and was reported outside the laboratory.The clinician did not agree with this result compared to the other biological and clinical tests performed.The patient was redrawn on (b)(6) 2017 and the result for this sample was 18.84 ug/l.The result from another cobas 8000 e 602 module was 19.05 ug/l.These results matched the other tests performed.The sample from (b)(6) 2017 was then repeated and the results were 46.18 ug/l and 37.29 ug/l.The results from the other cobas 8000 e 602 module were 35.16 ug/l and 35.82 ug/l.There was no allegation of an adverse event.The reagent lot number was 192154.The expiration date was requested but was not provided.The laboratory confirmed there was no mix up of the sample identification as all other parameters gave the same results.

Manufacturer Narrative

A specific root cause could not be determined.The most likely root cause was a preanalytical issue such as a centrifuge with a too high speed or a too short clotting time.These issues would result in clot formation in the sample and affect the sample quality.Other possible causes include insufficient maintenance or contamination of the environment with the analyte.The differences between the results from the different draw dates are very likely due to an unknown clinical status of the patient or due to medication.A general reagent issue was not suspected based on the provided qc data.

• Brand Name: COBAS 8000 E 602 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: 6493783
• MDR Text Key: 72956343
• Report Number: 1823260-2017-00779
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• 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
• Patient Age: 56 YR