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 02/05/2024

Event Type  malfunction  

Event Description

There was an allegation of incorrectly assigned results on an accu-chek inform ii meter, serial number (b)(6).The customer alleged that a glucose test was performed on a patient that was assigned to the wrong patient id when it was uploaded into the laboratory information system.The customer alleged that they could not find the result on the meter after it was uploaded.

Manufacturer Narrative

The customer stated that they scan the patients' wristbands to input the sample information on the meter prior to performing the test.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d9 and h3 were updated.The meter was received for investigation.The alleged issue was not reproducible.The investigation did not identify a product problem.The root 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
• 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: 18817789
• MDR Text Key: 336676860
• Report Number: 1823260-2024-00617
• 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,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1