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 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained a questionable low test result for one patient sample using the elecsys ferritin assay on the cobas 8000 e 602 module (e602).The initial ferritin result was 0.588 ng/ml.The repeat result was 3105 ng/ml.No adverse event occurred.The ferritin reagent lot number and expiration date was requested but not provided.Calibration was successful prior to the event.Customer performed a reagent probe check and the analyzer generated an abnormal reagent probe movement alarm.He believed the probe was hitting a closed reagent lid.The field service representative found the sample pipetter liquid level detector (lld) circuit was out of adjustment.He adjusted the lld, performed an instrument overview, and performed mechanism checks which passed.He conducted an assay performance check which was acceptable.The customer performed calibration and qc afterwards which passed.The instrument performed within specifications.The root cause for this event was the maladjusted sample pipetter lld circuit.This can cause an early lld signal, and therefore too little sample is pipetted.After service was performed, the analyzer worked according to specifications.

• 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: 6633183
• MDR Text Key: 77646473
• Report Number: 1823260-2017-01212
• Device Sequence Number: 0
• Product Code: JMG
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2017
• 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