MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 04745914001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be identified.The field service engineer confirmed the system was operating within specification.The customer has not had any other issues since the initial event.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for glucose hk gen.3 (gluc3).Erroneous results were reported outside of the laboratory.The initial gluc3 result at 10:39 p.M.Was 78.4 mg/dl.This result was reported outside of the laboratory.The physician requested that the sample be re-run due to wanting to make an adjustment to patient's insulin dose.The repeat result at 12:05 a.M.Was 788.1 with a data flag mg/dl.Insulin treatment was withheld until the result from the repeat test was known.It was noted that the patient was in "shock." the patient is currently in stable condition.No adverse event occurred due to the results from the instrument.The gluc3 reagent lot number was 608217.The expiration date was not provided.The last preventive maintenance performed on the analyzer was in (b)(6) 2014.

• Brand Name: COBAS 6000 C501 MODULE
• Type of Device: CLINICAL CHEMISTRY 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- 8504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4855721
• MDR Text Key: 14028489
• Report Number: 1823260-2015-03675
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/10/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 008 YR