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 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter's meter was requested for investigation.

Event Description

The initial reporter stated that when operators scanned a patient's arm band, accu-chek inform ii meter serial number (b)(4) displayed another patient's identifier.The reporter did not know if the operator performed a test on the patient after seeing another patient's identifier.The reporter did not know if results were charted under the wrong patient.

Manufacturer Narrative

The meter was not returned for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 12453766
• MDR Text Key: 272780704
• Report Number: 1823260-2021-02657
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1