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 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable low elecsys ca 19-9 immunoassay result for one patient sample.The initial result was 3 u/ml and was reported to the physician.As the patient had a previous ca 19-9 result from (b)(6) 2017 of 11820 u/ml, the physician questioned the reported result and requested the sample be repeated.The first repeat result was 41.77 u/ml.The laboratory then repeated the sample again with results of 10885 u/ml and 10505 u/ml.The patient had a new sample drawn on (b)(6) 2017 and the result was 11130 u/ml.The result of 10885 u/ml was believed to be correct.The patient was not adversely affected.The reagent lot number was 19394101 with an expiration date of 5/31/2018.The field service representative found there was possibly an issue with the sample or sample volume.He checked the sample and reagent flowpaths, pinch tubing, and reagent delivery.He ran performance testing and qc.

Manufacturer Narrative

A specific root cause could not be determined.Typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer.The provided calibration and qc data did not indicate a general issue with the analyzer, reagent, calibrator, or controls.

• 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: 6812792
• MDR Text Key: 83735232
• Report Number: 1823260-2017-01798
• Device Sequence Number: 0
• Product Code: NIG
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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: 08/04/2017
• 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: 61 YR