MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C502

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of a questionable result for 1 patient tested for a1c-3 tina-quant hemoglobin a1c gen.3 (hba1c) on a cobas 8000 c 502 module.Two separate doctors ordered hba1c testing on the same patient so the patient had two samples drawn at the same time.For sample a the initial hba1c result was 6.7% while sample b¿s initial hba1c result was 5.8%.The sample b result of 5.8% was reported outside of the laboratory.The doctor questioned the reported hba1c result due to the differences between sample a and sample b.Sample b was retested on (b)(6) 2017 and an hba1c result of 6.8% was obtained.The retest result of sample b was deemed to be correct and a corrected report was issued.The patient was not treated based on the original result.There was no adverse event.The samples were aliquoted by a modular pre-analytics analyzer.The hba1c reagent lot was 253327 with an expiration date of 31-jan-2019.The field engineering specialist was unable to find a cause.He checked the operation of the instrument.The customer ran calibration, qc, and precision testing which all passed.

Manufacturer Narrative

Further investigation of the analyzers alarm log showed multiple occurrences of "abnormal aspiration" alarms on the day of event.This indicates that a potential root cause could have been related to pre-analytical issues.Based on qc results a general instrument issues is not likely.There was no indication of a reagent problem.

• Brand Name: COBAS 8000 C 502 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: 7040585
• MDR Text Key: 93298571
• Report Number: 1823260-2017-02642
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C502
• Device Catalogue Number: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR