MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05060303001

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.

Event Description

The initial reporter had an issue while scanning patient id barcodes on an accu-chek inform ii meter.The reporter stated when she scans the patient id, it scans as one number but actually crossed into the software as another number.The patient id sample is (b)(4).However, it shows up in the software as 100589.There was no harm to any patient reported due to the issue.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

Manufacturer Narrative

The meter was received for investigation.The customer's meter barcode functionality was tested using sample barcodes.Various symbologies were scanned using the customer meter multiple times each.All of the barcodes were scanned correctly.No issue was found with the barcode scanning function of the meter.Barcode numbers were transferred to dms as patient id and no issues were found.The device was disassembled for further investigation.The visual inspection of the electronic parts showed no abnormalities.There was no contamination found.The barcode scanner window had light scuffs but this did not affect the scanning performance.The investigation did not identify a product problem.The investigation determined that the issue was due to the quality of the barcode the customer used.

• Brand Name: ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD
• 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: 12674066
• MDR Text Key: 277705377
• Report Number: 1823260-2021-03075
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• 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
• Patient Sequence Number: 1