MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable low ckl creatine kinase result for one patient sample.The initial result was 9 u/l and was reported outside the laboratory.The physician questioned the result because it did not agree with the clinical picture and the previous result of 1939 u/l.The sample was repeated and the result was 1565 u/l.This result was believed to be correct.The patient was not adversely affected.The reagent lot number was 20471501 with an expiration date of 11/30/2017.The customer stated the same sample generated an alarm indicating a clot when tested on another analyzer in the laboratory.The customer did not know if there was a clot in the sample at the time of the event.The field service representative determined the erroneous result was either due to a clot in the sample or the analyzer not detecting the sample was clotted.He checked the analyzer, verified the performance of the rinse mechanism, and checked all probe alignments.He ran a precision check with results well within guidelines.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the provided calibration, qc, and analyzer check data, instrument or reagent problems were ruled out.Since the same sample generated an alarm indicating a clot when tested on another analyzer in the laboratory, a preanalytic issue was suspected.

• Brand Name: COBAS 6000 C (501) MODULE
• 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: 6702813
• MDR Text Key: 79974602
• Report Number: 1823260-2017-01446
• Device Sequence Number: 0
• Product Code: CGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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