MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of erroneous results for 2 patients tested for elecsys hcg + beta test system (hcg + b) on a cobas 8000 e 602 module.Patient 1 initial hcg + b result was 1510 iu/l.This result was reported outside of the laboratory.On (b)(6) 2017 the sample was repeated twice with results of 324.8 iu/l and 326.3 iu/l.On (b)(6) 2017 a second sample was obtained for patient 1 and the initial hcg + b result on (b)(6) 2017 was 0.253 iu/l.The sample was repeated and the result was 0.222 iu/l.On (b)(6) 2017 the sample was repeated twice with results of 0.254 iu/l and 0.309 iu/l.On (b)(6) 2017 two sample tubes were collected at the same time from patient 2 ((b)(6)).The samples were visually checked for clots/fibrin and there were none.The initial hcg + b result was < 0.100 iu/l.This result was reported outside of the laboratory.Patient 2 went to the doctor on (b)(6) 2017 where a new sample was obtained and tested at a different laboratory where the hcg result was "(b)(6)." on (b)(6) 2017 the customer pulled both sample tubes that had been collected from the patient on (b)(6) 2017 and repeated them.The repeat results were 95.51 iu/l and 94.90 iu/l.An amended result was provided to the doctor.There was no allegation that an adverse event occurred.The hcg + b reagent lot number was 210151.The expiration date was not provided.The instrument has some dust on it but the environment is dusty and is wiped down every day.The alarm trace did not produce any sampling errors during the affected time period.Quality controls (qc) results appear to be acceptable.

Manufacturer Narrative

The field service engineer (fse) found that the clip holding down the pre-wash sippers was loose and not consistently holding the sippers in place.

Manufacturer Narrative

A specific root cause was not identified.The fse found that the clip that holds down the pre-wash sippers was loose.The pre-wash sipper 'washes' the assay prior to test measurement.If the pre-wash sipper is not in place correctly, the aspiration from the assay cup is incomplete.During the next refilling, the assay cup is over filled.This causes the assay to be diluted causing a low result.A potential root cause of the issue is related to service or customer maintenance during the cleaning of the sippers.Since the last service maintenance is documented as occuring in (b)(6) 2017, this potential root cause is unlikely.The instrument was working within specification after the service visit.

• 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: 6844768
• MDR Text Key: 85121562
• Report Number: 1823260-2017-01904
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 10/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 08/18/2017
• 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: 31 YR