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.
[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
Report Number | 1823260-2005-01887 |
MDR Report Key | 620483 |
Report Source | 04 |
Date Received | 2005-07-07 |
Date of Report | 2005-06-24 |
Date of Event | 2005-06-24 |
Date Mfgr Received | 2005-06-24 |
Device Manufacturer Date | 2004-04-01 |
Date Added to Maude | 2005-07-13 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | CHRISTOF LITTWITZ |
Manufacturer Street | 9115 HAGUE RD |
Manufacturer City | INDIANAPOLIS IN 46250 |
Manufacturer Country | US |
Manufacturer Postal | 46250 |
Manufacturer Phone | 3175212834 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACCU-CHEK COMPACT |
Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
Product Code | NBN |
Date Received | 2005-07-07 |
Returned To Mfg | 2005-07-15 |
Model Number | NA |
Catalog Number | 3149072 |
Lot Number | 20623744 |
ID Number | NA |
Device Expiration Date | 2005-10-30 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Age | NA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 610168 |
Manufacturer | ROCHE DIAGNOSTICS |
Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
Baseline Brand Name | ACCU-CHECK COMPACT |
Baseline Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
Baseline Model No | * |
Baseline Catalog No | 3149072 |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2005-07-07 |