MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 04882458001

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's meter and a barcode were requested for return.The customer's meter was returned for investigation.The customer has removed the 2d barcode scanning function on the meter.Also, the customer has reconfigured the patient id masking settings within the meter.The customer confirmed the issue has not recurred.The investigation is ongoing.Unique device identifier (udi) (b)(4).

Event Description

The initial reporter alleged that an accu-chek inform ii meter was not correctly scanning patient barcodes.The customer stated that the correct linear barcode was scanned, but when the patient's result was transferred to their third-party data management system, the patient id was flagged as invalid.Due to the flag, the customer had to manually match the correct patient id with the correct result.If the result cannot be matched with the correct patient id, the result is deleted from the data management system.The customer stated in their data management system, the invalid patient ids consisted of various numbers but usually start with an "8" or a "4." the customer confirmed the patient's armband has two barcodes present, the visit id and the medical record number.The visit id is the same number as the patient id.The visit id consisted of "pre" and then 7 digits, and the medical record number consisted of 6 digits.The meter was configured to use 1d barcode masking, and the masking was set as "***$$$$$$$." the minimum digit length was set as 7, and the maximum digit length was set as 20.The customer confirmed no incorrect results have been reported to a patient.

Manufacturer Narrative

The customer returned a physical barcode sample in the form of a patient wristband.The wristband contained two barcodes, one larger and one small barcode.The received wristband was not one that had allegedly scanned incorrectly.The received physical barcodes were scanned multiple times (>50 times) using the returned meter.Each barcode was scanned from varying distances, angles, and lighting conditions.The barcode was also curved to simulate how they would be worn on a patient's wrist.Each barcode was correctly read every single time.The customer meter barcode functionality was also tested using sample barcodes provided by the investigation unit.1d and 2d barcodes of various symbologies were scanned using the customer meter multiple times each.All barcodes were scanned correctly.No issue was found with the barcode scanning function of the meter.Visual inspection of the returned meter found no abnormatlities.Further analysis was performed on the returned sample barcodes using a barcode verifier.The analysis of the 2 "code 39" barcodes on the wrist band resulted in srp grade b for the smaller one and grade c for the larger one.The results indicate that the symbol height is too low and the spacing is too wide.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ACCU-CHEK INFORM METER
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11367103
• MDR Text Key: 268255450
• Report Number: 1823260-2021-00542
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04882458001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1