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

Model Number C501

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received a questionable c-reactive protein (crp) result for one patient sample.The initial result was 1.138 mg/dl and was reported to doctor who hospitalized the patient.At the hospital, the patient was retested for crp and the result did not agree with the initial result.No specific data could be provided.On (b)(6) 2015, the doctor asked customer to repeat the test.The sample from (b)(6) 2015 was tested with a result of 0.354 mg/dl.Of the data provided, the ion selective electrode (ise) potassium results for the sample were also discrepant.The initial result on (b)(6) 2015 was 4.62 and the repeat result on (b)(6) 2015 was 5.21.The unit of measure was not provided.The patient was not adversely affected.The crp reagent lot number was 616063.The expiration date was requested, but was not provided.The potassium electrode lot number and expiration date were requested, but were not provided.As multiple assays gave differing results upon repeat testing, a general instrument issue was suspected.It was noted the customer was not using the recommended sample tube rack adapters which might have allowed the sample tube to lean and led to a pipetting issue.

Manufacturer Narrative

A specific root cause could not be identified, but a preanalytic issue was suspected.A general reagent issue was not likely.The field service representative cleaned the rinse arm nozzles and probes, checked the volumes being pipetted, the tubes, valves, photometer, and mixer.All were acceptable.

• 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: 5332519
• MDR Text Key: 34597316
• Report Number: 1823260-2015-06142
• Device Sequence Number: 0
• Product Code: DCN
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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: 12/17/2015
• 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: 87 YR