MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® MOBILE TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number ASKU

Device Problem Overfill (2404)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Customer reportedly received results 498 mg/dl and 190 mg/dl within 10 minutes on the mobile system.The customer reports feeling dizzy with these results.No actions taken based on device results.No adverse event reported.Requested return of suspect device.

Manufacturer Narrative

The event occurred in (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

• Brand Name: ACCU-CHEK ® MOBILE TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3839645
• MDR Text Key: 20700367
• Report Number: 1823260-2014-03842
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: ASKU
• Device Lot Number: 278291
• Other Device ID Number: 00700006633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 079 YR