MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® MOBILE; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 06383645003

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Meter displays wrong unit of measure.Meter is labeled with "mmol/l" but displays results as mg/dl.No adverse event alleged.A request was made for the return of the device.

Manufacturer Narrative

Device was returned by customer to the manufacturer but device was lost by manufacturer before investigation could be completed.Manufacturer is unable to locate the device so no investigation of the device can be performed.

• Brand Name: ACCU-CHEK ® MOBILE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 6363998
• MDR Text Key: 68515216
• Report Number: 3011393376-2017-01192
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 06383645003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR