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

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of an erroneous high result for 1 patient tested for nh3l ammonia (nh3l).The erroneous result was reported outside of the laboratory.The initial nh3l result was 610.0 umol/l from the c501 analyzer.This result was reported outside of the laboratory where the doctor questioned it.A second sample was obtained and the result from a second c501 analyzer was 83.3 umol/l.The initial sample was repeated on the first c501 analyzer even though it was no longer on ice and the result was 76.7 umol/l.The initial sample was also repeated on the second c501 analyzer and the result was 71 umol/l.No adverse event occurred.The nh3l reagent lot number was 12955701 with an expiration date of 07/31/2017.The customer replaced the reaction cells before the event on (b)(6) 2016 and after the event on (b)(6) 2016.The field service engineer (fse) visited the customer site and checked multiple parts of the analyzer.Vacuum pump diaphragms were also checked and replaced even though they were not worn through.All analyzer specifications were within the appropriate guidelines and no adjustments were required.The fse ran precision tests and repeated the original sample in question 5 times.The results were repeated with no erroneous high results.Quality controls (qc) were acceptable and the customer began to run patient samples again.A specific root cause could not be identified.Additional information was requested for investigation, but was not provided.Based on the information available for investigation, an instrument and reagent issue can be excluded since calibration and qc were acceptable.The instrument was also checked by the fse and no issues were identified.Based on a review of the reaction monitor, the most likely root cause is a carry-over issue because the reaction curve provided for the initial result decreased abnormally.

Manufacturer Narrative

The customer has not had any further issues since the reaction cells were replaced on (b)(6) 2016 and the service visit by the fse.

• Brand Name: COBAS 6000 C501 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: 6033650
• MDR Text Key: 57629412
• Report Number: 1823260-2016-01581
• Device Sequence Number: 0
• Product Code: JIF
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• 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