MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS 2010 DISK; IMMUNOCHEMISTRY ANALYZER

Catalog Number 11568248001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for intact human chorionic gonadotropin + the b-subunit (hcg + b).It is not known if the erroneous results were reported outside of the laboratory.The initial hcg + b result was 183.4 miu/ml.The sample was repeated twice with results of 29.9 miu/ml and 3.03 miu/ml.No adverse event occurred.The hcg + b reagent lot number was 183183.The expiration date was not provided.The last routine maintenance visit was in 02/2015.It was noted that no quality controls (qc) were run prior to the event.Reagent 183183 had been onboard since (b)(6) 2015.On (b)(6) /2015 the customer had run liquid flow cleaning twice.The measuring cell was changed in march.The customer was advised to run calibration and qc.The calibration failed.The customer performed various maintenance activities on the instrument and calibration failed again.The field service application (fsa) specialist visited the customer site on 09/14/2015 and loaded a new reagent pack with lot number 185430 and calibrated again.Qc were too low with this new reagent.It was noted that the fsa identified "other tests with bad imprecision and accuracy results too." the details related to this statement have been requested.The customer was advised by the fsa to not operate the analyzer until all appropriate service actions are completed.It was noted that the customer manipulated the date in the system by one year to be able to use expired calibrator.Based on the available data, the issue seems to be instrument related; however, local reagent issues cannot be excluded.

Manufacturer Narrative

It was noted in the original report that the fsa identified "other tests with bad imprecision and accuracy results too." it was clarified that some of those affected tests were tsh, t4 and prl.No specific results were provided.No information was available from the customer as to whether there were additional discrepant results.It was clarified that the customer did not report any of the hcg + b results outside of the laboratory on the day of the initial event.On (b)(6) 2015 the customer indicated to the fsa that they had replaced the probe on the instrument due to a rupture with leakage and the instrument works fine now.It was noted that the customer did not purchase reagents from roche diagnostics.It was also noted that technical support for the instrument may be provided by a third party.Inappropriate service intervention cannot be excluded as a potential root cause.

Manufacturer Narrative

It was noted that the customer does not have a valid service contract with roche diagnostics.It is not known who provides technical support to the customer.It was also noted that no erroneous results have been reported outside of the laboratory.

Manufacturer Narrative

A roche field service engineer is not able to perform a service visit as the analyzer is owned by the customer and has no service contract with roche.

• Brand Name: ELECSYS 2010 DISK
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5114329
• MDR Text Key: 27148521
• Report Number: 1823260-2015-04249
• Device Sequence Number: 0
• Product Code: DHA
• Reporter Country Code: GR
• PMA/PMN Number: K961481
• 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: Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11568248001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/11/2015
• 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: 035 YR