MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSTANT TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Lot Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 05/03/2023

Event Type  Injury  

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

The patient's husband reported that the blood glucose monitor of the instant system was unavailable for use due to an error message, sample application not detected.He further mentioned that the customer, his wife, suffered from fainting and was in a coma.The patient was hospitalized for 15 days, and was stable again at the time of the report.The patient's husband could not provide the information how much time elapsed between the use of the meter and the fainting.No further details were provided regarding treatment in hospital.

• Brand Name: ACCU-CHEK ® INSTANT TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17783530
• MDR Text Key: 323864213
• Report Number: 3011393376-2023-02139
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female