MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 800; CLINICAL CHEMISTRY ANALYZER

Model Number I800

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained a questionable hba1c results for twelve patient samples using the a1c-2 tina-quant hemoglobin a1c gen.2 (hba1c) assay on the cobas integra 800 analyzer.Result data was provided for one of the samples.The initial results were released outside of the laboratory.No data flags or alarms occurred.The initial result was 4.4%.The physician questioned the result and requested a repeat of the sample.The customer had an issue with their deionized water system and was unable the repeat the sample until (b)(6) 2017.The repeat result on the same analyzer was 7.8%.The repeat result on another analyzer was 7.7%.The result of 7.8% was more in line with the patient's history.The customer pulled eleven other samples run on the original analyzer on (b)(6) 2017.The repeat results were "within 10% of the original result(s)." actual data was not provided.No adverse event occurred.The hba1c reagent lot number and expiration date were not provided.The field service representative checked the sample probe flow and the probe failed.He replaced the probe and repeated the flow checks which passed.He checked the light barrier adjustment, and performed a measurement and workstation accuracy check.All checks and diagnostic functions passed.The customer performed calibration and quality controls which passed.A performance check was acceptable.Investigation activities are ongoing.

Manufacturer Narrative

The following information was corrected: the customer had an issue with their middleware (not their water system) and was unable the repeat the sample until (b)(6) 2017.

Manufacturer Narrative

A specific root cause was not identified.Based on the information provided, the issue is related to the specific sample tested.Based on the quality control results, a general material problem is not suspected.Based on the fsr findings, there is no indication of a systemic failure of the roche product.The fsr did identify and correct a hardware issue, but it could not be determined if this was the actual root cause for the erroneous results.The customer has had multiple issues with hba1c results.The root cause is believed to be related to pre-analytical or maintenance issues.

• Brand Name: COBAS INTEGRA 800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6793772
• MDR Text Key: 83313272
• Report Number: 1823260-2017-01694
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• 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,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I800
• Device Catalogue Number: 28122474001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 07/25/2017
• Supplement Dates FDA Received: 08/25/2017; 09/13/2017
• 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: 47 YR