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 06/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer tested one patient sample with a glucometer and obtained a glucose result of 111 mg/dl.The sample was sent to the laboratory for confirmation.The customer obtained a questionable high result using the gluc3 glucose hk gen.3 (gluc3) assay on the cobas 6000 c (501) module.The initial result was 197 mg/dl.The result was released outside the laboratory to the physician who questioned it.The sample was repeated with a result of 107 mg/dl.No adverse event occurred.The gluc3 reagent lot number is 17931601 with an expiration date of 11/30/2017.The customer stated that qc for the amylase and ast assays have been running slight above the mean lately.The field service representative checked the detergent dispenser, sample dispenser, and gear pump pressure.He cleaned the valves and flushed the rinse mechanism tubing with bleach followed by deionized water.He checked probe alignments and adjusted rinse volumes.Investigation activities are ongoing.

Manufacturer Narrative

The issue resolved after the service activities.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The customer has had no further issues.

• 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: 6669477
• MDR Text Key: 78504326
• Report Number: 1823260-2017-01344
• Device Sequence Number: 0
• Product Code: CFR
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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: 06/13/2017
• 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: 39 YR