INFORM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-27 for INFORM * manufactured by Roche Diagnostics Corp..

Event Text Entries

[383094] A patient with history of diabetes, cardiac ejection fraction of 5%, severe peripheral edema. The blood sugar was drawn and sent to lab. The accucheck was done and the result was 486 it was repeated and the result was 338. Sliding scale insulin was given (9units). The lab results were called to floor and the results were 30. The patient went into respiratory arrest & was intubated. 3 hours later the accucheck was 70, a venous blood sugar was 12. The same meter displayed results of 104 & 157 from fingerstick, 137 from earlobe, and a lab result of 116 & 117. Lab qa person checked the equipment to verify correct function of the device. The lab reports a similar occurrence where a patient who was on 21 different medications had fingerstick results that did not correlate with the lab results, example: the fingerstick was 570, and the lab draw was 169 40 minutes later. This was reported to roche.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 609402
• MDR Report Key: 609402
• Date Received: 2005-05-27
• Date of Report: 2005-05-27
• Date of Event: 2005-05-18
• Report Date: 2005-05-27
• Date Reported to FDA: 2005-05-27
• Date Added to Maude: 2005-06-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INFORM
• Generic Name: ACCU-CHECK
• Product Code: CGA
• Date Received: 2005-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 599209
• Manufacturer: ROCHE DIAGNOSTICS CORP.
• Manufacturer Address: 9115 HAUGE RD. INDIANAPOLIS IN 46250 US

Device Sequence Number: 2

• Brand Name: COMFORT CURVE
• Generic Name: TEST STRIP
• Product Code: CFR
• Date Received: 2005-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: 548521
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 599210
• Manufacturer: ROCHE DIAGNOSTICS CORP.
• Manufacturer Address: 9115 HAUGE RD. INDIANAPOLIS IN 46250 US

Device Sequence Number: 3

• Brand Name: COMFORT CURVE
• Generic Name: CONTROL SOLUTION
• Product Code: LIE
• Date Received: 2005-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 599211
• Manufacturer: ROCHE DIAGNOSTICS CORP.
• Manufacturer Address: 9115 HAUGE RD. INDIANAPOLIS IN 46250 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2005-05-27