MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Model Number C311

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained questionable high test results for three patient samples using the ureal urea/bun (bun) assay on the cobas 4000 c (311) stand alone system (c311).The physician questioned all results, and the samples were sent to another laboratory where the results were "normal." of the three samples, only the result data for one sample was provided.All results are in units of mg/dl, and all were released outside of the laboratory.The initial result was 55.The physician questioned the result, so the sample was sent to another laboratory.The result from the second laboratory's roche c6000 instrument was 15.On (b)(6) 2017, the customer recalibrated the bun assay and repeated the sample on their c311.The result was 15.Both results of 15 were deemed correct.No adverse event occurred.The bun reagent lot number is 21831701 with an expiration date of 10/31/2017.After the event, the customer continued to test bun on their c311, and was performing qc on the assay twice per day.The field service representative found that the sample probe was not aligned properly over the rinse station which prevented the probe from getting a proper outside rinse.He performed a sample probe alignment over the rinse station, check all other alignment positions, and checked the rinse mechanism for proper fluidics function.Qc was acceptable, and the customer would run qc every four hours to monitor.The customer did not feel that a sample probe misalignment issue was the cause.The customer agreed the bun reagent had been on-board the analyzer for two weeks and the calibration curve could have drifted out of specification.After the assay was recalibrated, the issue seemed to resolve.Investigation activities are ongoing.

Manufacturer Narrative

The customer did not feel that the issue was caused by the misaligned sample probe, nor that the previous service activities resolved the issue.The customer believed that the calibration curve had drifted and the assay needed recalibrated.The customer recalibrated the assay and they stated that the issue resolved.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• Brand Name: COBAS 4000 C (311) STAND ALONE SYSTEM
• 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: 6666292
• MDR Text Key: 78398420
• Report Number: 1823260-2017-01332
• Device Sequence Number: 0
• Product Code: CDQ
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C311
• Device Catalogue Number: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• 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: 17 YR