MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 04882458001

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.

Event Description

The initial reporter complained of a display issue with an accu-chek inform ii meter.The customer alleged lines were present in the middle of the display screen and at the bottom of the display screen near where the date is located.The customer is able to use the meter for testing, however, the lines affect the area where test results are displayed which could affect the interpretation of patient results.No patient results have been misinterpreted.

Manufacturer Narrative

The reporter's meter was returned for investigation.After powering on the meter the visual inspection of the display showed a thick black line running horizontal at the bottom of the display.Black lines are formed when air enters into the lcd cell by small separations in the glue.Due to the observed drop damage on the meter housing and damage to the lcd, it is possible that the glue became separated due to the force of contact with a hard surface.Therefore, it is determined that the formation of the black lines were caused by customer mishandling.Medwatch fields d9 and h3 have been updated.

• Brand Name: ACCU-CHEK INFORM METER
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10438659
• MDR Text Key: 203916391
• Report Number: 1823260-2020-02057
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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: 04882458001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1