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

Model Number E602

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).Medwatch field phone number was provided as (b)(6).Medwatch field fax number was provided as (b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys total psa immunoassay (tpsa) on a cobas 8000 e 602 module (e602).The erroneous result was reported outside of the laboratory to the doctor.The sample initially resulted with no value, only a data flag.The sample was repeated, resulting as 0.019 ng/ml.The result was discrepant from what was expected for the patient.The customer expected a value around 10 ng/ml.The sample was repeated on 11/29/2016, resulting as 10.71 ng/ml.The patient was not adversely affected.The tpsa reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

The field service engineer checked the system and found that the sample probe was dirty.He cleaned it.No further issues were observed.The root cause of the issue was determined to be a contaminated sample probe.

• 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: 6169875
• MDR Text Key: 62471184
• Report Number: 1823260-2016-01947
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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: 11/30/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• 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