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

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

It was reported that the bolus recommendations provided by the blood glucose monitor are not accurate.

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.

• 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: 16962265
• MDR Text Key: 315933903
• Report Number: 3011393376-2023-01168
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.
• Patient Age: 16 YR
• Patient Sex: Female