Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM BASE; BLOOD GLUCOSE MONITORING DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS ACCU-CHEK INFORM BASE; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Catalog Number 04882300001
Device Problem Electrical Shorting (2926)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
The customer¿s products have been 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.
 
Event Description
The initial reporter had an issue with the accu-chek inform ii meter.He stated the left charging contact appears brown, as if toasted.The base unit appeared to be burnt only on the tip of the left charging contact.The charging contacts on the meter did not appear to be affected.There was no smoke, fire, or injury.
 
Manufacturer Narrative
Customer's base unit was was received for investigation.Corrosion was observed on one of the charging contacts.The corrosion on the charging contact was caused by contamination due to improper cleaning.Medwatch fields d10 and h3 have been updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCU-CHEK INFORM BASE
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10264721
MDR Text Key199908160
Report Number1823260-2020-01675
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K012210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04882300001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-