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

Catalog Number 05060303001

Device Problems Insufficient Information (3190); Patient Data Problem (3197)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

We received an allegation that glucose results from the accu-chek inform ii meter were assigned to the incorrect patient.The reporter stated that at 10:28 pm, patient a's meter result of 10.0 mmol/l was correctly transmitted to their laboratory information system (lis).At 10:30 pm, the reporter stated that they performed a meter test on patient b and the result was 15.5 mmol/l on the meter.When they checked the lis, they found that this result was tagged to patient a.They then checked the meter and found that 2 results (10.0 mmol/l and 15.5 mmol/l) were both tagged to patient a and patient b's results could not be found on the meter.The reporter stated that they correctly scanned the patient ids.They performed another test on patient b and the result was correctly assigned to the patient.

Manufacturer Narrative

The investigation is ongoing.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18994202
• MDR Text Key: 338888451
• Report Number: 1823260-2024-00944
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1