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

Catalog Number 05990378001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received an erroneous result for one patient sample tested for ferritin on an e602 analyzer.The sample initially resulted as 1.19 ug/l and this value was reported outside of the laboratory to the physician.The physician did not trust the result and asked for the sample to be repeated.The sample was repeated on the same analyzer, resulting as 20.17 ug/l.The sample was also repeated on an e170 analyzer, resulting as 18.46 ug/l.The repeat result was believed to be correct.The patient was not adversely affected.The ferritin reagent lot number was 121669.The reagent expiration date was asked for, but not provided.The field service engineer found that reagent cups on the analyzer were dirty.He cleaned the cups and performed a measuring cell preparation.He checked sample adjustment and this was ok.He did not detect any other issues with the system.He ran performance testing.He stated that the overall cleanliness of the laboratory was good.

Manufacturer Narrative

It was stated that the performance testing run on the analyzer was successful.A specific root cause could not be determined based on the provided information.A general reagent or instrument issue could not be seen.

• 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: 5529344
• MDR Text Key: 41264418
• Report Number: 1823260-2016-00351
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/22/2016

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 Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• 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: 39 YR