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

Model Number	06870287001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Power Problem (3010)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
At 8:30 am the patient received a blood glucose result in the 200's mg/dl on her aviva system.Based on the elevated result the patient increased her insulin dosage and took 20 units of novolog insulin at 8:30 am.The patient's normal dosage is 10 units of novolog.The patient went to a routine doctor's appointment at 11:00 am and the doctor checked the patient's blood glucose and received a result of 113 mg/dl on the doctor's meter.At 1:00 pm upon arriving home the husband states the patient was pale and unresponsive, but conscious.The husband attempted to test the patient at 1:00 pm with the aviva meter but received an e-9 message.The husband then phoned accu-chek and a meter reset was performed.At 1:20 pm while on the line troubleshooting, the husband was able to re-test the patients blood glucose and received a result of 108 mg/dl.The patient was slumped over in the chair.The husband disconnected the call with accu-chek and called 911.The husband called the emt's at 1:35 pm and the emt's arrived around 1:50 pm.Upon arrival the emt's received a blood glucose result of 48 mg/dl on their professional meter.The emt's treated the patient with a peanut butter sandwich and orange juice.The husband then treated the patient with a ham sandwich.The patient began to fell better within 8-9 minutes.The emt's rechecked the patient's blood glucose before they left and received a reading of 54 mg/dl.The patient was not taken to the hospital.
Additional Manufacturer Narrative
Corrected to provide the correct suspect device information.
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 ® 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
• Manufacturer (Section G): SANMINA CORPORATION; 13000 south memorial parkway; na; huntsville AL 35803 1025
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9642445
• Report Number: 3011393376-2020-00318
• Device Sequence Number: 2179673
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,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?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2020
• Device Model Number: 06870287001
• Device Catalogue Number: 06908217001
• Device Lot Number: 498315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 03/06/2020; 07/22/2025
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/28/2020; 03/09/2020; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVOLOG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG