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

Catalog Number 05346754160

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

The reporter stated that the numbers on the display on the accutrend plus meter (serial number (b)(4)) are partial.The reporter stated that this display issue was noted during a control result.She does not remember what the control result was or what part of the display was missing.She stated that the meter had been at room temperature for 24 hours prior to when the partial display was noted.The issue did not occur during any patient testing.A picture of the display check done on receipt of the meter shows that segments are missing in all of the numbers, both in the results field and the date and time stamp fields.Further evaluation is in progress.There was no adverse event.The meter was requested to be returned and a replacement was sent.

Manufacturer Narrative

The meter was returned and the display failure was confirmed.The display is damaged and when the meter was opened the display was found to be very dirty on the inside.It was determined that the meter either fell, was dropped, or received a forceful blow.The housing was damaged on the right side, close to the display.It was determined that the root cause of the reported failure is due to an operator handling failure.

• 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: 5651427
• MDR Text Key: 45101670
• Report Number: 1823260-2016-00627
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 05346754160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• 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