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

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable high gluc3 glucose hk results for an unknown number of patient samples.One example was provided as an initial result of 150 mg/dl and a repeat result of 107 mg/dl.Erroneous results were reported outside the laboratory.There was no allegation of an adverse event.The reagent lot number was 193436.The expiration date was requested but was not provided.A specific root cause could not be determined.Review of the provided calibration data did not indicate a reagent issue but due to multiple errors found, an issue with the calibrator handling or the analyzer performance was suspected.Imprecision and sporadic outliers in the qc data indicated an issue with the gear pump, the wash efficiency, or the sample/reagent probe pipetting was possible.

• 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: 6417460
• MDR Text Key: 70419325
• Report Number: 1823260-2017-00582
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: Other
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• 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
• Date Manufacturer Received: 01/18/2017
• 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