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

Model Number COBAS 6000 CORE

Device Problem Low Test Results (2458)

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

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable ise indirect k for gen.2 results for potassium (k) for one patient sample on a cobas 6000 core unit.The patient¿s initial result was 2.52 mmol/l, which was reported outside the laboratory.The sample was repeated with results of 4.25 mmol/l and 4.21 mmol/l.The result of 4.21 mmol/l was sent as a corrected report.The sample was received from a "health center" where it was previously centrifuged.The sample was checked and there was no visible issue with sample quality.The patient was not adversely affected.The potassium electrode lot number is 123456.The expiration date was requested but not provided.The customer checked the probes and found no issues nor residue.Calibration and qc was acceptable.

Manufacturer Narrative

A specific root cause for this event could not be identified.Additional information was requested for investigation but was not provided.A possible root cause may be related to pre-analytics and sample handling (needle lubricant, fibrin, or microclots in the initial sample).

• 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: 6396706
• MDR Text Key: 69759089
• Report Number: 1823260-2017-00529
• Device Sequence Number: 0
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/30/2017

1 Device was Involved in the Event

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: 04745868001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• 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: 83 YR