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

Model Number	08387052001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The caller alleged an incident where the meter was unavailable for use due to an e-4 message on (b)(6) 2021, at an unknown time.The customer experienced symptoms of high blood glucose levels consisting of headache and sweating.The customer was incapable of providing self-treatment at the time of the error message.At 1:00am, the customer was able to get a successful reading of 400 mg/dl.The reporter stated that after the 400 mg/dl reading, she provided the customer with 34 units of long acting insulin (unable to recall the name).She called the va nurse because she was uncertain if she had administered the insulin correctly.The customer is scheduled to take 40 units of insulin, but out of fear and her non experience with administering medication she only provided him with 34 units.She retested the customer with the nurse on the phone, and the result was 300 mg/dl at 1:15am.The nurse advised to recheck later, because his levels were decreasing.The final reading was at 3:00am, and the result was 200 mg/dl.The reporter stated it is hard to determine how the customer is feeling based on his other health conditions.The customer always has headache which is a primary symptom of his trigeminal nerve condition.The reporter stated she is unable to determine when the customer felt better after receiving the insulin because he is always in pain due to other health conditions.On (b)(6) 2021, the customer was diagnosed with stage 4 cancer; type of cancer was not provided.The customer was not taken to the hospital, nor emts were called.The treatment was provided at home by a friend calling and reporting the information.The reporter is not alleging that the meter caused or contributed to the incident.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: ACCU-CHEK ® GUIDE ME
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ALTEK MEDICAL LIMITED.; 3rd main street; 2f, building no. 1; jiangsu AL 21530 1; CH 215301
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12711853
• Report Number: 3011393376-2021-03360
• Device Sequence Number: 17337083
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Other
• Device Model Number: 08387052001
• Device Catalogue Number: 08387052001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 07/22/2025
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/18/2021; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARBAMAZEPINE.; LONG LASTING INSULIN.; CARBAMAZEPINE; LONG LASTING INSULIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 89 KG