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

Catalog Number 06908217001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Loss of consciousness (2418)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

It was unknown if the initial reporter sent a report to the fda.

Event Description

Customer reportedly received a normal blood sugar reading of 100 mg/dl thirty minutes prior to passing out with low blood sugar and was treated with 2 doses of glucose gel and a glucose iv by paramedics; was not able to self treat.Customer took his normal dose of lantus 22 units after the reading; did not eat breakfast or exercise.There were reportedly 2 military officers that were nearby and called the paramedics.Customer stated that he believes the paramedics probably arrived 5 minutes later.Customer stated that he stores his unexpired aviva plus test strips in a old competitor's test strip vial that is smaller and fits better in his pocket.Requested return of the alleged device for evaluation and replacement was sent.

• Brand Name: ACCU-CHEK ® AVIVA PLUS 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, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 6838086
• MDR Text Key: 84351611
• Report Number: 3011393376-2017-04920
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 06908217001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LANTUS INSULIN; NOVOLOG INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 90