MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS INSULIN; IMMUNOREACTIVE INSULIN TEST SYSTEM

Catalog Number 12017547122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has discarded the reagent pack in question.

Event Description

The customer complained of issues with elecsys insulin quality controls (qc) since (b)(6) 2017 on a cobas 8000 e 602 module.The customer stated qc started to drift low on (b)(6) 2017 while using reagent lot 157805-01.Qc was run on (b)(6) 2017 and the results were out of range.Qc was rerun and the results were acceptable.Later that day when qc was run, the results had drifted out again.At this point, the customer pulled all of the patients that had been previously tested for insulin and repeated the samples.Out of 12 patient samples, corrected reports were issued for 5 of them.Based on the data provided for these 5 patient samples, the results for 2 patient samples were erroneous and had been reported outside of the laboratory.Patient 1 initial insulin result was 12.86 uu/ml.The repeat result was 24.1 uu/ml.Patient 2 ((b)(6) male) initial insulin result was 14 uu/ml.The repeat result was 30 uu/ml.The customer put a new reagent pack on the instrument of 157805-02.Qc has been fine since using the new reagent pack.The customer indicated this reagent pack was from the same shipment as the previous reagent pack.The customer thinks the issue was limited to the one reagent pack.The customer discarded the reagent pack in question.No adverse event occurred.The e602 module serial number was (b)(4).The field service engineer (fse) visited the customer site.The instrument was checked and no problems were found.The insulin results have been steady since the customer replaced the reagent pack in question.The calibration and qc data provided by the customer are within specifications.A specific root cause could not be identified.A general reagent issue was not observed since the qc data provided was within expectations.Potential root causes of the drifting qc results and the discrepant results are likely related to transportation, storage, contamination or handling issues of the insulin reagent pack with 157805-01.The issue was solved by replacing the reagent pack.

Manufacturer Narrative

The customer stated there have not been issues with any other reagent packs.The issue only occurred with the particular reagent pack mentioned in this complaint.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6342974
• MDR Text Key: 68101636
• Report Number: 1823260-2017-00379
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001104
• 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,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 12017547122
• Device Lot Number: 15780501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• 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: 24 YR