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

Catalog Number 05899311001

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

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

Event Date 03/23/2024

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.H3 other text : shipment of complaint material from russia suspended indefinitely.

Event Description

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

• 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: 18988183
• MDR Text Key: 338729951
• Report Number: 3011393376-2024-00730
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05899311001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male