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

Model Number	06908349001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient received a high blood glucose result of 200 mg/dl while experiencing an episode of hypoglycemia.Around 4-5pm, the patient's symptoms of low blood sugar were impaired speech, no control over his body movements, and he was incoherent.The patient did not treat during this time.Between 6-7pm, the customer began to have a seizure.Due to the impact of the seizure, the customer was not capable of performing a blood test on his own.Therefore, his son performed a blood test for him and received a result of 200 mg/dl.The customer's son called the emts around 7pm.When the emts arrived they performed a blood test on their meter and result was 50 mg/dl.Based on the result, the patient was treated with a gel substance and was transported to the medical center for additional treatment.They arrived at 9:59pm to the medical center, where the patient received an iv, but he does not know what medication he received.The customer was not admitted into the medical center, but was kept for several hours for observation.The customer was discharged about 2:45am with a steady blood glucose level and arrived back home about 3:00am on (b)(6) 2021.The patient was using expired strips when he received the result of 200 mg/dl.

• Brand Name: ACCU-CHEK AVIVA PLUS TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12035687
• Report Number: 3011393376-2021-01881
• Device Sequence Number: 4154346
• Product Code: NBW
• UDI-Device Identifier: 00365702438101
• UDI-Public: 00365702438101
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K101299
• 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
• Report Date (Section B): 08/30/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 06908349001
• Device Catalogue Number: 06908349001
• Device Lot Number: 497504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIPIZIDE ORAL MEDICATION; LANTUS INSULIN; METFORMIN ORAL MEDICATION
• Patient Age: 76 YR
• Patient Weight: 91