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

Catalog Number 05060303001

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.The meter was returned for investigation and the issue could not be reproduced.The meter was working within specifications.Visual investigation of the meter housing did not reveal any external hardware defects or contamination.The meter was disassembled for further investigation.Visual inspection of the electronic parts showed no abnormalities or contamination.

Event Description

The initial reporter stated that accu-chek inform ii meter serial number (b)(4) misread a patient identifier barcode.The event occurred in (b)(6) 2020.The specific date of the event was not provided.The meter scanned the patient identifier correctly more than 90 % of the time.The barcode symbology used by the customer is code 128.The patient identifier of (b)(6) was misread as (b)(6).The misreads occurred on two occasions.The issue could be reproduced upon reprint of the barcode from the patient's actual wristband.The reporter stated they discovered the issue because the incorrect patient identifier of (b)(6) matched the patient identifier of a patient who hadn't been to the hospital for any tests on days the misreads occurred.No results were reported to patients who were actively in the hospital.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10195981
• MDR Text Key: 203130096
• Report Number: 1823260-2020-01549
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05060303001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• 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