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 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous high results for 8 patient samples tested for ca2 calcium gen.2 (ca2) on a cobas 6000 c (501) module.The erroneous results were reported outside of the laboratory.Refer to the attached data for patient results.The repeat results were believed to be correct.No adverse event occurred.The ca2 reagent lot number was 208643.The expiration date was not provided.

Manufacturer Narrative

The field service engineer (fse) visited the customer site.The customer had water system maintenance while the instrument was running.This caused calcium rich water to enter the system.The fse primed the system with deionized water and the system functioned per specification.A 21 cup precision check was performed and the results were within specification.The customer ran calibration and quality controls with acceptable results and no further ca2 issues.No abnormal trends in the past 90 days for elevated calcium results after water system maintenance were found.There has been no similar event at this site within the previous 12 months with a similar or unknown root cause.

• 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: 6656986
• MDR Text Key: 78151146
• Report Number: 1823260-2017-01289
• Device Sequence Number: 0
• Product Code: CJY
• 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: 07/11/2017

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: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 06/02/2017
• Supplement Dates FDA Received: 07/11/2017
• 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