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

Device Problem Complete Loss of Power (4015)

Patient Problem Hyperglycemia (1905)

Event Date 02/24/2022

Event Type  Injury  

Event Description

The caller reported that the blood glucose monitor was unavailable for use due to power concerns.At 5:00am on (b)(6) 2022 the customer experienced elevated blood glucose symptoms of vomiting, feeling dizzy, and a stomach ache.The customer was unable to test her blood glucose due to the meter not turning on.At an unknown time the customer became unconscious.At 11:00am the customer's father transported her to the hospital.Upon arrival at the hospital, the customer's blood glucose was over 600 mg/dl and she was admitted into the intensive care unit.The hospital placed the customer on a respirator and treated her with unknown solutions.The customer was discharged from the hospital on (b)(6) 2022.

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: 14025287
• MDR Text Key: 288774719
• Report Number: 3011393376-2022-01062
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female