MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND ® PLUS; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05346754160

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the display on the accutrend plus meter was faulty.The code number was not completely displayed and some of the numbers were not fully showing.A display check was performed and none of the segments were missing.The screen was not fading nor was the window cloudy.There was no erroneous result generated and there was no adverse event.The suspect meter was replaced.The meter was received for investigation and the failure could be confirmed.The middle character of the code or the result was displayed incorrectly.The root cause for the reported failure was misuse of the meter for example a fall or from being dropped.The function of the meter was tested and was ok.The customer was advised about the correct handling of the meter.

• Brand Name: ACCUTREND ® PLUS
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6064505
• MDR Text Key: 58770678
• Report Number: 1823260-2016-01673
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05346754160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1