MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number COBAS 6000 CORE

Device Problem High Test Results (2457)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of a discrepant bilt3 bilirubin total gen.3 (bilt3) result on one neonate patient.The initial bilt3 result was 508.5 ¿mol/l.The patient had phototherapy along with a glucose infusion started based on this initial result.The physician did not believe the initial result and requested the sample to be retested along with having another blood sample drawn.The repeat bilt3 result from the original sample was 290 ¿mol/l.The redraw sample also had a bilt3 result of <300 ¿mol/l.The repeat result was deemed to be correct and the glucose infusion and phototherapy were stopped.There was no allegation that the patient was adversely affected and was released and sent home.The reagent lot and expiration date for the bilt3 was requested but not provided.Other testing that was performed concurrently with the initial bilt3 testing had a sample alarm that is often associated with a pipetting error caused by a clot.The investigation is currently ongoing.

Manufacturer Narrative

Further investigation showed that the discrepant result was most likely related to a sample clot and that sample handling and pre-analytics could have been the cause.

• Brand Name: COBAS 6000 CORE UNIT
• Type of Device: CLINICAL CHEMISTRY 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: 6954179
• MDR Text Key: 90584669
• Report Number: 1823260-2017-02345
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060373
• 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
• Report Date: 11/01/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS 6000 CORE
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1