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 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable low elecsys testosterone ii assay result for one patient sample.The initial result for an aliquot of the sample processed by the modular preanalytic analyzer (mpa) was 8 ng/dl and was reported outside of the laboratory.On (b)(6) 2017, the physician questioned the result and the customer repeated the sample.The result from the aliquot of the sample was 624 ng/dl.The result from the primary sample tube was 598 ng/dl.The repeat results were believed to be correct.The patient was not adversely affected.The reagent lot number was 19105300 with an expiration date of 28-feb-2018.The field service representative could not find a cause.He ran mechanical checks and performance testing which passed, checked the probe positions, and primed the system.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer.

• 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: 6999860
• MDR Text Key: 92073855
• Report Number: 1823260-2017-02526
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR