MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® NANO; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 06337538001

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 05/13/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reporter alleged she attempted to test on the nano system when she was feeling symptoms of low blood sugar, but couldn't get a result due to an error message (e-1)(damaged test strip).Reporter tested on friend's meter with a reading of 69 mg/dl; friend helped by placing some sugar in her mouth.There was no delay in treatment.Reporter stated that emts were called and they obtained a reading of 108 mg/dl on their meter; emts did not treat the customer.Customer no longer has the strips.Requested return of suspect device, and replacing meter and strips.

• Brand Name: ACCU-CHEK ® NANO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): SANMINA-SCI CORPORATION; 13000 south memorial parkway; 13000 south memorial parkway; huntsville IN 46250
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3888978
• MDR Text Key: 21156352
• Report Number: 1823260-2014-04591
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2014

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 Catalogue Number: 06337538001
• Other Device ID Number: 00700006648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/11/2014; 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCOCET 10/325; ASPIRIN; CANE; LANTUS; FLUOXETINE; BUPROPION HCL; GABAPENTIN; METHADONE HCL; LOSARTAN; NOVOLOG; WALKER
• Patient Outcome(s): Required Intervention
• Patient Age: 056 YR
• Patient Weight: 91