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 Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient sample tested for elecsys ferritin (ferritin) on two cobas 8000 e 602 modules.This medwatch will cover e 602 module with serial number (b)(4) (module a).Refer to medwatch with a1 patient identifier (b)(6) for information on e602 module with serial number (b)(4) (module b).The initial ferritin result from e602 with serial number (b)(4) (module b) was 3.6 ng/ml.The sample was repeated on e602 with 16m1-19 (module a) and the result was 2.6 ng/ml.The result of 2.6 ng/ml was reported outside of the laboratory where it was questioned by the patient.On (b)(4) 2017 the sample was repeated on 2 additional e602 modules (module c and module d).The repeat result from e602 module c was 513.1 ng/ml.The repeat result from e602 module d was 543.6 ng/ml.The result of 543.6 ng/ml was believed to be correct.There was no allegation that an adverse event occurred.The ferritin reagent lot number was 192154.The expiration date was not provided.On the day of the event there were several instrument alarms related to abnormal sample probe movement and abnormal sample aspiration on e602 with serial number (b)(4).

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.The most likely root cause is related to pre-analytical issues since several sample alarms were detected on the day of the event.The alarms the customer received could be caused by temporary foam or bubbles on the sample surface; an insufficient sample volume; tilted sample tubes in combination with wet tube walls; or fibrin clots/strands caused by inadequate preanalytical handling.An additional possible root cause for this event may be insufficient maintenance.

• 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: 6979832
• MDR Text Key: 91097134
• Report Number: 1823260-2017-02426
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• 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: 43 YR