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

Model Number C501

Device Problem Device Handling Problem (3265)

Patient Problem Misdiagnosis (2159)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

The incorrect result occurred due to a configuration error at the customer site.The units set in the instrument were incorrect (ug/ml).The correct units for this application are mg/dl.Product labeling provides instruction on how to define the unit of measure for an application.The investigation did not identify a product problem.

Event Description

The initial reporter complained of a sali salicylate (sali) result for 1 patient that was reported outside of the laboratory in the wrong units of measure on a cobas 6000 c (501) module.The result from the instrument was 102.9 ug/ml.The result was reported outside of the laboratory as 102.9 mg/dl.The sample was repeated and the result was 113.3 ug/ml.The incorrect result occurred due to a configuration error at the customer site.The units set in the instrument were incorrect (ug/ml).The correct units for this application are mg/dl.The result using the correct units would have been 10.3 mg/dl and would have been believed to be correct.The patient was treated based on the result going out as 102.9 mg/dl.The patient had their stomach pumped and was transferred to icu.The patient received dialysis treatment and was placed on suicide watch.The patient's medical history, medications, clinical condition at the time of testing and current condition were requested but could not be provided.There was no allegation of any serious adverse health consequences due to the treatment received.The sali reagent lot number was 43267401 with an expiration date of 31-jan-2021.

• 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: 10002980
• MDR Text Key: 194159320
• Report Number: 1823260-2020-01121
• Device Sequence Number: 1
• Product Code: JJE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/03/2020
• 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 Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 84