MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of a discrepant result for elecsys ca 19-9 immunoassay (ca 19-9) result for one patient sample.The customer sent the patient sample out to an external laboratory and the discrepant result was generated by their cobas 6000 e 601 module (e601).The patient had an initial (sample 1) ca 19-9 result of 200 u/ml on (b)(6) 2017.Sample 1 initial result was not reported outside of the laboratory.Sample 1 was repeated and a result of 198 u/ml was obtained which was deemed correct.The testing was performed on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).The patient mentioned that they went to another hospital or laboratory and they had a result that meets expectations.Specific information regarding which system and an exact results could not be obtained.A new blood draw was performed on (b)(6) 2017 (sample 2).Sample 2 was tested for ca 19-9 on a cobas 8000 e 801 module and an initial result of 315 u/ml and a repeat result of 317 u/ml was obtained.The initial result was not reported outside of the laboratory.Sample 2 was sent to an external laboratory (lab 1).Lab 1 tested sample 2 for ca 19-9 on an e601 on (b)(6) 2017.The ca 19-9 result was 3 u/ml.Sample 2 was sent to another external laboratory (lab 2) and ca 19-9 testing was performed on a siemens system.A ca 19-9 result of 70 u/ml was obtained.The expected value for the competitor system was < 30 u/ml.Sample 2 was sent to another external laboratory (lab 3).Lab 3 tested sample 2 for ca 19-9 on a e601 on (b)(6) 2017.The ca 19-9 result was 291.5 u/ml sample 2 was sent to another external laboratory (lab 4).Lab 4 testing was performed on (b)(6) 2017 and a ca 19-9 result of 307 u/ml was obtained from an unknown system.Unless noted all results were reported outside of the laboratory.For sample 2 the correct result was deemed to be around 300 u/ml.There was no allegation of an adverse event.The ca 19-9 reagent lot was 21361200 with an expiration date of 31-oct-2018.The investigation is currently ongoing.

Manufacturer Narrative

Analysis of qc testing showed no indication of a general system or reagent issue.Foam was found on the sample.An exact root cause could not be determined.Other possible root causes include tilted tubes in combination with wet tube walls or fibrin clots or strands caused by insufficient pre-analytical handling.

• Brand Name: COBAS 6000 E 601 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: 6968390
• MDR Text Key: 90793641
• Report Number: 1823260-2017-02399
• Device Sequence Number: 0
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• 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