MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK PERFORMA COMBO; BLOOD GLUCOSE MONITORING DEVICE

Device Problem Inadequate User Interface (2958)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that a button on the infusion device was defective.

• Brand Name: ACCU-CHEK PERFORMA COMBO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12412538
• MDR Text Key: 269526647
• Report Number: 3011393376-2021-02694
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/03/2021
• 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