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

Catalog Number 05346754160

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s meter was requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.The investigation did not identify a product problem.The cause of the event could not be determined.The event occurred in: (b)(6).

Event Description

The initial reporter complained of a display issue with an accutrend plus meter serial number (b)(4) that could impact the interpretation of patient results.The customer stated that there were digits, segments, letters, symbols, and/or icons that were displayed incompletely or incorrectly.This could impact the interpretation of patient results.There were no reports of any patient results being misinterpreted.

• 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: 8860886
• MDR Text Key: 153814973
• Report Number: 1823260-2019-02838
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K944459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

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: Health Professional
• Device Catalogue Number: 05346754160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/05/2019
• 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