ACCU-CHEK COMPACT 3149072

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-07-07 for ACCU-CHEK COMPACT 3149072 manufactured by Roche Diagnostics.

Event Text Entries

[418018] Customer reported device = 365 mg/dl. Customer was teken to the hosp and their device = 147 mg/dl. No treatment was received. Controls were used but not certain if values are within range. A request was made for return product and replacement product was sent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2005-01887
MDR Report Key620483
Report Source04
Date Received2005-07-07
Date of Report2005-06-24
Date of Event2005-06-24
Date Mfgr Received2005-06-24
Device Manufacturer Date2004-04-01
Date Added to Maude2005-07-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTOF LITTWITZ
Manufacturer Street9115 HAGUE RD
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175212834
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCU-CHEK COMPACT
Generic NameBLOOD GLUCOSE MONITORING DEVICE
Product CodeNBN
Date Received2005-07-07
Returned To Mfg2005-07-15
Model NumberNA
Catalog Number3149072
Lot Number20623744
ID NumberNA
Device Expiration Date2005-10-30
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key610168
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE RD. INDIANAPOLIS IN 46250 US
Baseline Brand NameACCU-CHECK COMPACT
Baseline Generic NameBLOOD GLUCOSE MONITORING DEVICE
Baseline Model No*
Baseline Catalog No3149072
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2005-07-07

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