MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous low results for 4 patient samples tested for either insulin or connecting peptide (c-peptide).It is not clear if the results are from 4 different patients or if the results are from different samples from the same patient.It is not known if any erroneous results were reported outside of the laboratory.Patient sample 1 initial insulin result was <0.2 uu/ml.The repeat result was 82.6 uu/ml.Patient sample 2 initial insulin result was <0.2 uu/ml.The repeat result was 5.1 uu/ml.Patient sample 3 initial c-peptide result was <0.1 ng/dl.The repeat result was 4.3 ng/dl.Patient sample 4 initial c-peptide result was <0.1 ng/dl.The repeat result was 2.8 ng/dl.No adverse event occurred.The insulin and c-peptide reagent lot numbers and expiration dates were not provided.A system maintenance check was last performed on 05/25/2016.The customer site was visited by the field service engineer (fse) and no instrument issues were identified which would have affected the measurement of the results.Bubbles were identified in the reagent.The customer has had no further issues with erroneous results.A general instrument issue can most likely be excluded based on the data provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the information available, the bubbles in the reagent, identified by the fse, are the most likely root cause of the erroneously low results.

• Brand Name: COBAS 6000 E601 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: 5738943
• MDR Text Key: 47905708
• Report Number: 1823260-2016-00790
• Device Sequence Number: 0
• Product Code: CFP
• Reporter Country Code: JA
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• 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?: No
• Date Manufacturer Received: 06/09/2016
• 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