MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUCHEK INSTANT PLUS; CHOLESTEROL (TOTAL) TEST SYSTEM

Catalog Number 03965708001

Device Problems Circuit Failure (1089); Display Difficult to Read (1181)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was an allegation of a display issue with an accuchek instant plus.The display is missing some segments.The customer cannot clearly read the cholesterol results.The screen is not damaged.The meter is used for cholesterol testing only right now.

Manufacturer Narrative

The production of this meter ceased in 2008.The customer's meter was replaced with a current product.

• Brand Name: ACCUCHEK INSTANT PLUS
• Type of Device: CHOLESTEROL (TOTAL) TEST SYSTEM
• 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: 12555663
• MDR Text Key: 274466895
• Report Number: 1823260-2021-02860
• Device Sequence Number: 1
• Product Code: CHH
• UDI-Device Identifier: 75537009765
• UDI-Public: 75537009765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03965708001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2021
• 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
• Patient Sequence Number: 1